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Trial record 82 of 760 for:    Area Under Curve AND meal

Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals

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ClinicalTrials.gov Identifier: NCT02397265
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Bi-hormonal closed loop pump
Device: Standard opened loop pump
Device: Insulin closed loop
Enrollment 24
Recruitment Details 24 participants were recruited (due to 4 withdrawals before randomization) to reach a total n=20 for the study. Only 6 were randomised/completed due to sufficient data, rest of 14 people did not do the study. 6 people were randomized and completed the study for each arm. The interventions were in random order according to the randomisation.
Pre-assignment Details  
Arm/Group Title First Bihormonal Closed Loop First Standard Opened Loop Pump First Insulin Only
Hide Arm/Group Description Bihormonal Closed Loop first, then Standard Opened Loop Pump, then Insulin First Standard Opened Loop Pump, then Bihormonal Closed Loop, then Insulin First Insulin, then Standard Opened Loop Pump, then Bihormonal Closed Loop
Period Title: First Intervention of Three
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: Second Intervention of Three
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: Third Intervention of Three
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Arm/Group Title All Participant
Hide Arm/Group Description Crossover study, all participant
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
55
(50 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 6 participants
6
1.Primary Outcome
Title Percentage of Time in Target Range Over 24 Hour
Hide Description The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bihormonal Closed Loop Standard Opened Loop Pump Insulin Only
Hide Arm/Group Description:

Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies

Bi-hormonal closed loop pump: Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump

Standard opened loop pump will be used in the exercise and mixed meal substudies

Standard opened loop pump: Using a standard opened loop pump

Insulin only closed loop
Overall Number of Participants Analyzed 6 6 6
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
2
(0.4 to 3)
4.7
(1.8 to 12)
1.3
(0.4 to 7.2)
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bihormonal Closed Loop Standard Opened Loop Pump Insulin Only
Hide Arm/Group Description

Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies

Bi-hormonal closed loop pump: Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump

Standard opened loop pump will be used in the exercise and mixed meal substudies

Standard opened loop pump: Using a standard opened loop pump

Insulin only closed loop
All-Cause Mortality
Bihormonal Closed Loop Standard Opened Loop Pump Insulin Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bihormonal Closed Loop Standard Opened Loop Pump Insulin Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bihormonal Closed Loop Standard Opened Loop Pump Insulin Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
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: Nick Oliver
Organization: Imperial College London
Phone: 020 7594 2460
EMail: nick.oliver@imperial.ac.uk
Publications:
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02397265     History of Changes
Other Study ID Numbers: 14SM2107
First Submitted: March 5, 2015
First Posted: March 24, 2015
Results First Submitted: July 12, 2019
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019