Trial Outcomes & Findings for Clinical Assessment of a Closed-loop Insulin Delivery System (NCT NCT01534013)

Results Overview

Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

18 months

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Closed-loop Insulin Delivery The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.	Open-loop Insulin Delivery glucose sensor and insulin pump
Overall Study STARTED	8	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed-loop Insulin Delivery n=8 Participants The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.	Open-loop Insulin Delivery n=6 Participants standard insulin pump therapy	Total n=14 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 10 • n=8 Participants	45 years STANDARD_DEVIATION 10 • n=6 Participants	45 years STANDARD_DEVIATION 10 • n=14 Participants
Sex: Female, Male Female	5 Participants n=8 Participants	4 Participants n=6 Participants	9 Participants n=14 Participants
Sex: Female, Male Male	3 Participants n=8 Participants	2 Participants n=6 Participants	5 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
HbA1c	7.4 percentage STANDARD_DEVIATION 0.7 • n=8 Participants	7.4 percentage STANDARD_DEVIATION 0.7 • n=6 Participants	7.4 percentage STANDARD_DEVIATION 0.7 • n=14 Participants

PRIMARY outcome

Timeframe: 18 months

Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

Outcome measures

Outcome measures
Measure	Closed-loop Insulin Delivery n=8 Participants The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes The Imperial College Closed-Loop Insulin Delivery System: The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.	Open-loop Insulin Delivery n=6 Participants sensor augmented pump therapy
Percentage Time in Euglycaemia	71 percentage of time	66.9 percentage of time

SECONDARY outcome

Timeframe: 18 months

Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in hypoglycaemia is to be calculated using these blood glucose values.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during patient visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Glycaemic variability as measured by MAGE and SD Calculation using CGM data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Glycaemic risk as measured by LBGI and HBG Calculation using CGM data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Closed loop error grid analysis Calculation using CGM data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Glucose area under the curve Calculation using CGM data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Calculation using average insulin delivered per hour and bodyweight

Outcome measures

Outcome data not reported

Adverse Events

Closed-loop Insulin Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open-loop

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

Prof Nick Oliver

Imperial College London

Phone: 02075942433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place