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Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)

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ClinicalTrials.gov Identifier: NCT00831389
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : October 11, 2012
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Type 1 Diabetes Mellitus
Intervention Device: Closed Loop
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title First Standard of Care or Open Loop, Then CLosed Loop First Closed Loop, Then Standard of Care or Open Loop
Hide Arm/Group Description All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Period Title: Overall Study
Started 6 7
Completed 6 6
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title First Closed Loop, Then Standard of Care or Open Loop First Standard of Care or Open Loop, Then CLosed Loop Total
Hide Arm/Group Description First Closed Loop, Then Standard of Care or Open Loop First Standard of Care or Open Loop, Then CLosed Loop Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
7
 100.0%
4
  66.7%
11
  84.6%
Between 18 and 65 years
0
   0.0%
2
  33.3%
2
  15.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
14.4  (2.1) 17.7  (4.7) 15.9  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
3
  42.9%
3
  50.0%
6
  46.2%
Male
4
  57.1%
3
  50.0%
7
  53.8%
1.Primary Outcome
Title Plasma Glucose (PG) Response to Exercise
Hide Description PG at start of exercise minus the subsequent PG nadir
Time Frame Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
75
(48 to 100)
90.5
(59.75 to 105)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.791
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Incidence of Hypoglycemia Immediately Following Exercise
Hide Description Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Time Frame Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: hypoglycemic events
0
(0 to 0)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Incidence of Nocturnal Hypoglycemia Following Exercise
Hide Description Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Time Frame Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: hypoglycemic events
0
(0 to 1)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Peak Post-prandial Plasma Glucose (PG)
Hide Description For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
Time Frame Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
188
(162.5 to 227.875)
229.75
(207.875 to 242.375)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0669
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Nadir Plasma Glucose (PG) Immediately Following Exercise
Hide Description The PG nadir observed following the start of exercise
Time Frame Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
80.5
(65.75 to 120.75)
70.5
(66.75 to 80.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2256
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Overnight Nadir Plasma Glucose (PG)
Hide Description For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
Time Frame Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
74.5
(61.375 to 109.625)
93.5
(84.5 to 97.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.791
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
Hide Description For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Time Frame Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
74.1
(66.2 to 81.4)
79.8
(73.3 to 83.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2036
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
Hide Description For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Time Frame Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
19.7
(6.7 to 32.6)
17.3
(15.6 to 21.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6221
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
Hide Description For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Time Frame Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
6
(0.1 to 10)
1.1
(0.5 to 2.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Post-Hoc Outcome
Title Overall Incidence of Hypoglycemia
Hide Description Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Time Frame Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were used for final analysis
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description:
Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: hypoglycemic events
3
(0 to 5.5)
1
(0.75 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care (OL) Phase, Closed Loop (CL) Phase
Comments Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments p < 0.05 is considered significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care (OL) Phase Closed Loop (CL) Phase
Hide Arm/Group Description Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
All-Cause Mortality
Standard of Care (OL) Phase Closed Loop (CL) Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Standard of Care (OL) Phase Closed Loop (CL) Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care (OL) Phase Closed Loop (CL) Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/13 (7.69%)    
Skin and subcutaneous tissue disorders     
Erythema   0/13 (0.00%)  0 1/13 (7.69%)  2
Pruritus   0/13 (0.00%)  0 1/13 (7.69%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Harry Clark
Organization: Medtronic Diabetes
Phone: 818-576-5653
EMail: bud.clark@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00831389    
Other Study ID Numbers: ePID-03
First Submitted: January 26, 2009
First Posted: January 28, 2009
Results First Submitted: June 8, 2012
Results First Posted: October 11, 2012
Last Update Posted: December 12, 2017