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Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT01859312
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : November 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adrenal Insufficiency
Excess Androgen
Congenital Adrenal Hyperplasia (CAH)
Interventions Drug: Hydrocortisone (Solucortef)
Device: Insulin pump (Medtronic)
Enrollment 8
Recruitment Details Eight adult patients with classic CAH due to 21-hydroxylase deficiency participated in this study. Four were recruited from a pool of 147 patients enrolled on a natural history study at the NIH natural history study (NCT00250159); 4 were recruited through advertisements.
Pre-assignment Details  
Arm/Group Title Continuous Sub-Q Hydrocortisone Infusion
Hide Arm/Group Description

Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to achieve near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Period Title: Overall Study
Started 8
Completed 8 [1]
Not Completed 0
[1]
Based on medication & supply accountability, one participant was found to be partially non-compliant
Arm/Group Title Continuous Sub-Q Hydrocortisone Infusion
Hide Arm/Group Description

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
United States
5
  62.5%
Canada
3
  37.5%
Phenotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Simple Virilizing (SV)
2
  25.0%
Salt-wasting (SW)
6
  75.0%
1.Primary Outcome
Title Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  37.5%
3.Secondary Outcome
Title Participants Mean Level of 17-OHP at 0700
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/dL
8313  (2748)
4.Secondary Outcome
Title Participants Mean Level of 17-OHP at 0700
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/dL
2150  (531)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
98.5  (39.3)
6.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
25.7  (9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
48.6  (22.4)
8.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
6.8  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
20.5  (6.8)
10.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
7.5  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
29.5  (11.1)
12.Secondary Outcome
Title Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description 17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
11.4  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Participants Mean Level of Androstenedione at 0700
Hide Description Participants Mean Level of Androstenedione at 0700.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/dL
748  (295)
14.Secondary Outcome
Title Participants Mean Level of Androstenedione at 0700
Hide Description Participants Mean Level of Androstenedione at 0700.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/dL
317  (77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
12.7  (4.5)
16.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
5.2  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
5.3  (2.1)
18.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
1.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
3.7  (1.1)
20.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
1.6  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
3.7  (1.3)
22.Secondary Outcome
Title Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*mcg/dL
1.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Participants Mean Level of ACTH at 0700
Hide Description Participants Mean Level of ACTH at 0700.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: pg/mL
405  (114)
24.Secondary Outcome
Title Participants Mean Level of ACTH at 0700
Hide Description Participants Mean Level of ACTH at 0700.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: pg/mL
139  (47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
2538  (743)
26.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
1087  (359)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
1239  (402)
28.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
340  (107)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
29.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
458  (179)
30.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
183  (55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
31.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
841  (233)
32.Secondary Outcome
Title Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaenous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*pg/mL
564  (216)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaenous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.524
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
33.Secondary Outcome
Title Participants Mean Progesterone Levels at 0700
Hide Description Participants Mean Level of Progesterone at 0700
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/mL
9.5  (5.4)
34.Secondary Outcome
Title Participants Mean Progesterone Level at 0700
Hide Description Participants Mean Level of Progesterone at 0700
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/mL
0.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Other Statistical Analysis Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.
35.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
101.1  (48.8)
36.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
13.7  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
37.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
42.2  (20.0)
38.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
4.2  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
39.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
30.7  (17.7)
40.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
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Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
5.5  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
41.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At baseline
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[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
28.2  (12.5)
42.Secondary Outcome
Title Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Hide Description Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time Frame At 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: h*ng/dL
4.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Subcutaneous Hydrocortisone Infusion
Comments Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
43.Secondary Outcome
Title Participant Lean Body Mass
Hide Description lean body mass measured by DEXA, Hologic Discovery-A
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: kg
60.7  (3.7)
44.Secondary Outcome
Title Participant Lean Body Mass
Hide Description lean body mass measured by DEXA, Hologic Discovery-A
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description:

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: kg
64.3  (4.4)
Time Frame At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
Adverse Event Reporting Description

IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected:

  1. Local skin reaction (50%)
  2. Local skin infection requiring local or antibiotic treatment (10%)
  3. Minimal bleeding after removal of the infusion set (90%)
 
Arm/Group Title Continuous Subcutaneous Hydrocortisone Infusion
Hide Arm/Group Description

Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy

Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

All-Cause Mortality
Continuous Subcutaneous Hydrocortisone Infusion
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Subcutaneous Hydrocortisone Infusion
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Subcutaneous Hydrocortisone Infusion
Affected / at Risk (%)
Total   8/8 (100.00%) 
Ear and labyrinth disorders   
Tinnutus   1/8 (12.50%) 
Gastrointestinal disorders   
Nausea   2/8 (25.00%) 
Decreased appetite   2/8 (25.00%) 
Increased appetite   6/8 (75.00%) 
General disorders   
Fatigue   7/8 (87.50%) 
Difficulty falling asleep or frequent wakening   5/8 (62.50%) 
Early morning wakening   3/8 (37.50%) 
Weight gain   5/8 (62.50%) 
Musculoskeletal and connective tissue disorders   
Weakness   3/8 (37.50%) 
Carpal tunnel   1/8 (12.50%) 
Knee pain when walking   1/8 (12.50%) 
Nervous system disorders   
Dizziness   5/8 (62.50%) 
Lightheadedness   5/8 (62.50%) 
Headache   7/8 (87.50%) 
Skin and subcutaneous tissue disorders   
Skin erythema with pruritis at the infusion set site   3/8 (37.50%) 
Local skin infection at the infusion set site   5/8 (62.50%) 
Increased acne   2/8 (25.00%) 
Indicates events were collected by systematic assessment
All patients completed the study; according to medication and supply accountability, one patient was found to be partially non-compliant, the pump was disconnected approximately 30% of the time. When this patient was excluded, analysis were the same.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deborah P. Merke, MD, MS
Organization: National Institute of Child Health and Human Development (NICHD)
Phone: 301-496-0718
EMail: DMerke@cc.nih.gov
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01859312     History of Changes
Other Study ID Numbers: 130121
13-CH-0121 ( Other Identifier: National Institute of Child Health and Human Development )
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: August 30, 2017
Results First Posted: November 22, 2017
Last Update Posted: December 22, 2017