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Trial record 54 of 748 for:    Area Under Curve AND meal

New Strategies for Postprandial Glycemic Control Using Insulin Pump Therapy

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ClinicalTrials.gov Identifier: NCT01550809
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Collaborators:
European Union
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Fundación para la Investigación del Hospital Clínico de Valencia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Other: iBolus
Other: tBolus (traditional bolus)
Enrollment 12
Recruitment Details Twelve patients were recruited in this two-way, crossover study. One factor was the type of the insulin bolus administered (iBolus or tBolus). The other factor was the amount of carbohydrates (Low- or High-CHO meal) ingested. Recruitment started in February 2010 and was terminated by the end of June 2011
Pre-assignment Details

Subjects received the i- or the tBolus on the first meal study (either Low or High CHO), according to one of the following sequences:

  1. iBolus first+low CHO first
  2. iBolus first+high CHO first
  3. tBolus first+low CHO first
  4. tBolus first+high CHO first

Each one of the four meal tests was performed 1-2 weeks apart from the others

Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Hide Arm/Group Description Traditional mealtime bolus based on the individual insulin-to-CHO ratio This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
Period Title: Overall Study
Started 6 [1] 6 [2]
Completed 6 6
Not Completed 0 0
[1]
Six patients started with the tBolus, the others with the iBolus, according to a crossover design.
[2]
Six patients started with the iBolus, the others with the tBolus, according to a crossover design.
Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration) Total
Hide Arm/Group Description Traditional mealtime bolus based on the individual insulin-to-CHO ratio This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
43.6  (6.8) 40.3  (7.9) 41.8  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
4
  66.7%
5
  83.3%
9
  75.0%
Male
2
  33.3%
1
  16.7%
3
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).
Hide Description

AUC-PG0-5 h (5-hour postprandial glucose following the mixed meal test) is a measure of the overall glucose-lowering efficacy of the insulin bolus. The lower the AUC-PG0-5 h without hypoglycemia, the greater the effectiveness of the prandial insulin administration to control the meal related glucose excursion.

Plasma glucose (PG) for calculation of AUC-PG was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes).

Time Frame The whole experiment, i.e. 5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This was a proof-of-concept study. However, as an estimation of N, a two-sided t-test achieved 84% power to infer that the mean difference was not 0 when the total sample size of a 2x2 crossover design was 12, the actual mean difference in the AUC-PG0-5 h was 100mg*dl-1*h, the square root of the within mean square error was 75.0 and alpha was 0.05.
Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Hide Arm/Group Description:
Traditional mealtime bolus based on the individual insulin-to-CHO ratio
This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg*h/dl
724.6  (198.7) 668.8  (162.7)
2.Primary Outcome
Title The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).
Hide Description

The amount of glucose infused during the 5-hour postprandial period (AUC-GIR0-5h) is a measure of the hypoglycemic exposure associated with the modality of prandial insulin administration. Indeed, glucose will be infused only when patients are under a predefined blood glucose values (80 mg/dl) with a descending trend.

Glucose infusion rate (GIR) for calculation of AUC-GIR was measured every minute following the insulin administration and during the whole 5-hour postprandial period (300 minutes).

Time Frame The whole experiment, i.e. 5 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Hide Arm/Group Description:
Traditional mealtime bolus based on the individual insulin-to-CHO ratio
This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg/kg
55.0  (103.3) 119.6  (167.0)
3.Secondary Outcome
Title The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).
Hide Description

The AUC-PG>140 during the 5-hour period following the meal test represents the hyperglycemic risk related to the modality of prandial insulin administration.

Plasma glucose (PG) for calculation of AUC-PG>140 was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes).

Time Frame The whole experiment, i.e. the 5-hour postprandial period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Hide Arm/Group Description:
Traditional mealtime bolus based on the individual insulin-to-CHO ratio
This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg*h/dl
111.1  (176.6) 89.3  (144.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Hide Arm/Group Description Traditional mealtime bolus based on the individual insulin-to-CHO ratio This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
All-Cause Mortality
tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
tBolus (Traditional Bolus) iBolus (CGM-based Insulin Administration)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Francisco Javier Ampudia Blasco
Organization: Departamento de Endocrinología y Nutrición, Hospital Clínico Universitario de Valencia, Universitat de València, Valencia, Spain
Phone: +34 96 3862665
EMail: Francisco.J.Ampudia@uv.es
Layout table for additonal information
Responsible Party: Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01550809     History of Changes
Other Study ID Numbers: FP7-PEOPLE-2009-IEF #252085
DPI2010-20764-C02-01 ( Other Grant/Funding Number: Spanish Ministry of Science, DPI2010-20764-C02-01 )
First Submitted: February 28, 2012
First Posted: March 12, 2012
Results First Submitted: June 5, 2012
Results First Posted: August 29, 2012
Last Update Posted: August 29, 2012