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Trial record 15 of 2454 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents

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ClinicalTrials.gov Identifier: NCT01890954
Recruitment Status : Completed
First Posted : July 2, 2013
Results First Posted : April 15, 2015
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Chernavvsky, MD, CRC, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Device: Diabetes Assistant (DiAs)
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care First, Then Closed Loop Control Closed Loop Control First, Then Usual Care
Hide Arm/Group Description 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
Period Title: Overall Study
Started 9 8
Completed 8 8
Not Completed 1 0
Arm/Group Title Usual Care First, Then Closed Loop Control Closed Loop Control First, Then Usual Care Total
Hide Arm/Group Description 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
8
 100.0%
8
 100.0%
16
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
15  (2) 15  (2) 15  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
4
  50.0%
4
  50.0%
8
  50.0%
Male
4
  50.0%
4
  50.0%
8
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
8
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
8
 100.0%
8
 100.0%
16
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Percent of Time Spent Near Normoglycemia
Hide Description Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control With DiAs System Usual Care Without DiAs System (CGM Only)
Hide Arm/Group Description:
8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: percentage time near normoglycemia
Overall (8 hours) 43.4  (6.5) 18.9  (7)
Post-snack (4 hours) 45.1  (8.7) 21.3  (7.7)
Post-lunch (4 hours) 42.3  (9.2) 16.9  (7.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Closed Loop Control With DiAs System Usual Care Without DiAs System (CGM Only)
Hide Arm/Group Description

8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch

Diabetes Assistant (DiAs)

8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
All-Cause Mortality
Closed Loop Control With DiAs System Usual Care Without DiAs System (CGM Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Closed Loop Control With DiAs System Usual Care Without DiAs System (CGM Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Closed Loop Control With DiAs System Usual Care Without DiAs System (CGM Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
BG values followed 4 h after the unannounced meals, risk for hypoglycemia could have been detected if followed longer AP system was tested in adolescents with diabetes well controlled (average HbA1c 8.2) adolescents in worst control may benefit most
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: Daniel Chernavvsky
Organization: University of Virginia
Phone: 434-243-1395
EMail: drc2v@virginia.edu
Layout table for additonal information
Responsible Party: Daniel Chernavvsky, MD, CRC, University of Virginia
ClinicalTrials.gov Identifier: NCT01890954     History of Changes
Other Study ID Numbers: 16890
First Submitted: June 27, 2013
First Posted: July 2, 2013
Results First Submitted: April 3, 2015
Results First Posted: April 15, 2015
Last Update Posted: June 5, 2017