Trial Outcomes & Findings for Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004) (NCT NCT00977808)

Results Overview

Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Overnight (21:30 until 08:00)

Results posted on

2014-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Adults With Type 1 Diabetes During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump. At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician.
Overall Study STARTED	12
Overall Study Completion of Open-Loop Admission	12
Overall Study Completion of Closed-Loop Admission	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With Type 1 Diabetes n=11 Participants During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump. At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.17 years STANDARD_DEVIATION 10.31 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Overnight (21:30 until 08:00)

Population: Only participants who completed both study periods were considered for this assessment.

Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).

Outcome measures

Outcome measures
Measure	Experimental: Closed-Loop Model Predictive Control (MPC) n=11 Participants Insulin dosing was performed by a model-predictive control (MPC) algorithm.	Control: Open-Loop n=11 Participants Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
Occurrence of Hypoglycemic Episodes	5 Hypoglycemic Episodes	23 Hypoglycemic Episodes

Adverse Events

Adults With Type 1 Diabetes

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

Boris Kovatchev, Ph.D./Principal Investigator

University of Virginia

Phone: 434-982-6479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place