Trial Outcomes & Findings for Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation (NCT NCT01945138)

NCT ID: NCT01945138

Last Updated: 2017-07-31

Results Overview

Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 3 days of investigation period
• Results posted on: 2017-07-31

Participant Flow

Participant milestones

Measure	Control Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Baseline characteristics by cohort

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).	Total n=14 Participants Total of all reporting groups
Age, Continuous	33.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	38.6 years STANDARD_DEVIATION 9.4 • n=7 Participants	35.9 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Weight at Transplant	76.7 kg STANDARD_DEVIATION 23.7 • n=5 Participants	66.1 kg STANDARD_DEVIATION 10.3 • n=7 Participants	71.4 kg STANDARD_DEVIATION 18.4 • n=5 Participants
Body Mass Index (BMI) at Transplant	24.9 kg/m2 STANDARD_DEVIATION 5.7 • n=5 Participants	25.3 kg/m2 STANDARD_DEVIATION 4.5 • n=7 Participants	25.1 kg/m2 STANDARD_DEVIATION 4.9 • n=5 Participants
hemoglobin A1c (A1c)	5.4 % STANDARD_DEVIATION 0.5 • n=5 Participants	5.1 % STANDARD_DEVIATION 0.2 • n=7 Participants	5.3 % STANDARD_DEVIATION 0.4 • n=5 Participants
Fasting Blood Glucose (BG)	95 mg/dL STANDARD_DEVIATION 13 • n=5 Participants	89 mg/dL STANDARD_DEVIATION 6 • n=7 Participants	92 mg/dL STANDARD_DEVIATION 10.3 • n=5 Participants
Fasting C-Peptide	95 ng/mL STANDARD_DEVIATION 13 • n=5 Participants	89 ng/mL STANDARD_DEVIATION 6 • n=7 Participants	92 ng/mL STANDARD_DEVIATION 10.3 • n=5 Participants
Peak Mixed Meal Tolerance Test (MMTT) C-peptide	5.8 ng/mL STANDARD_DEVIATION 4.4 • n=5 Participants	6.4 ng/mL STANDARD_DEVIATION 2.2 • n=7 Participants	6.1 ng/mL STANDARD_DEVIATION 3.4 • n=5 Participants
Islet Yield	4245 IEq/kg STANDARD_DEVIATION 2174 • n=5 Participants	6619 IEq/kg STANDARD_DEVIATION 3357 • n=7 Participants	5432 IEq/kg STANDARD_DEVIATION 2983 • n=5 Participants
Days on drip	6.9 days STANDARD_DEVIATION 1.1 • n=5 Participants	5.1 days STANDARD_DEVIATION 1.1 • n=7 Participants	6.0 days STANDARD_DEVIATION 1.4 • n=5 Participants
Etiology of Chronic Pancreatitis (CP) Identified Genetic Mutation (PRSS1, SPINK1, CFTR)	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Etiology of Chronic Pancreatitis (CP) Mechanical Dysfunction	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Etiology of Chronic Pancreatitis (CP) Idiopathic Pancreatitis	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days of investigation period

Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Average Serum BG	130 mg/dL Standard Deviation 13	111 mg/dL Standard Deviation 4

PRIMARY outcome

Timeframe: 3 days of investigation period

Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Serum BG Standard Deviation	21.0 mg/dL Standard Deviation 10.2	14.1 mg/dL Standard Deviation 3.3

SECONDARY outcome

Timeframe: continuously over the 72 hour investigational period

Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Continuous Glucose Monitor (CGM) BG Average	125 mg/dL Standard Deviation 20	114 mg/dL Standard Deviation 4

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Continuous Glucose Monitor Standard Deviation of BG	21.0 mg/dL Standard Deviation 10.3	20.1 mg/dL Standard Deviation 5.1

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Percent Time BG in Range 70-140 mg/dL	70.6 % of time Interval 48.0 to 93.1	89.2 % of time Interval 83.5 to 94.8

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL	1615 min*mg/dL/day Standard Deviation 4267	146 min*mg/dL/day Standard Deviation 270

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: % of Time CGM BG <70 mg/dL	4.8 % of time Interval -6.9 to 16.6	1.1 % of time Interval -0.3 to 2.6

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: CGM AUC With Glucose> 140 mg/dL	7860 min*mg/dL/day Standard Deviation 11444	2025 min*mg/dL/day Standard Deviation 1177

SECONDARY outcome

Timeframe: continuous over the 72 hour investigation period

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: % of Time CGM BG > 140 mg/dL	23.7 % of time Interval 1.5 to 46.0	9.7 % of time Interval 4.9 to 14.5

SECONDARY outcome

Timeframe: Average of 3 day study period

A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Morning C-peptide	1.6 ng/mL Standard Deviation 1.0	1.3 ng/mL Standard Deviation 0.6

SECONDARY outcome

Timeframe: Average of 3 day study period

Calculated as total daily dose of insulin.

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Study Period: Daily Insulin Needs	0.56 U/kg/day Standard Deviation 0.31	0.26 U/kg/day Standard Deviation 0.17

SECONDARY outcome

Timeframe: Day 14 Follow-Up

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Day 14 Follow-Up: Average Serum BG	135 mg/dL Standard Deviation 81	106 mg/dL Standard Deviation 16

SECONDARY outcome

Timeframe: Day 14 Follow-Up:

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Day 14 Follow-Up: C-Peptide	1.0 ng/mL Standard Deviation 0.9	1.6 ng/mL Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day 28 Follow-Up

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Day 28 Follow-Up: Average Serum BG	113 mg/dL Standard Deviation 29	100 mg/dL Standard Deviation 21

SECONDARY outcome

Timeframe: Day 28 Follow-Up

Outcome measures

Measure	Control n=7 Participants Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 Participants Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Day 28 Follow-Up: C-Peptide	1.0 ng/mL Standard Deviation 1.2	1.7 ng/mL Standard Deviation 1.2

Adverse Events

Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Closed Loop Insulin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=7 participants at risk Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.	Closed Loop Insulin n=7 participants at risk Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Endocrine disorders Mild Hypoglycemia	14.3% 1/7 • Number of events 2	42.9% 3/7 • Number of events 3
Nervous system disorders Seizure	14.3% 1/7 • Number of events 1	0.00% 0/7

Additional Information

Dr. Melena Bellin

University of Minnesota

Phone: 612-624-5409

Email: bell0130@umn.edu

Results disclosure agreements

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