Trial Outcomes & Findings for Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals (NCT NCT02397265)

NCT ID: NCT02397265

Last Updated: 2019-11-01

Results Overview

The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2019-11-01

Participant Flow

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.

Participant milestones

Measure	First Bihormonal Closed Loop Bihormonal Closed Loop first, then Standard Opened Loop Pump, then Insulin	First Standard Opened Loop Pump First Standard Opened Loop Pump, then Bihormonal Closed Loop, then Insulin	First Insulin Only First Insulin, then Standard Opened Loop Pump, then Bihormonal Closed Loop
First Intervention of Three STARTED	2	2	2
First Intervention of Three COMPLETED	2	2	2
First Intervention of Three NOT COMPLETED	0	0	0
Second Intervention of Three STARTED	2	2	2
Second Intervention of Three COMPLETED	2	2	2
Second Intervention of Three NOT COMPLETED	0	0	0
Third Intervention of Three STARTED	2	2	2
Third Intervention of Three COMPLETED	2	2	2
Third Intervention of Three NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Participant n=6 Participants Crossover study, all participant
Age, Continuous	55 years n=6 Participants
Sex: Female, Male Female	4 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=6 Participants
Region of Enrollment United Kingdom	6 participants n=6 Participants

PRIMARY outcome

Timeframe: 24 hours

The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).

Outcome measures

Measure	Bihormonal Closed Loop n=6 Participants 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 n=6 Participants 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 n=6 Participants Insulin only closed loop
Percentage of Time in Target Range Over 24 Hour	2 percentage of time Interval 0.4 to 3.0	4.7 percentage of time Interval 1.8 to 12.0	1.3 percentage of time Interval 0.4 to 7.2

Adverse Events

Bihormonal Closed Loop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Opened Loop Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Oliver

Imperial College London

Phone: 020 7594 2460

Email: nick.oliver@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place