Trial Outcomes & Findings for Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone (NCT NCT00797823)

NCT ID: NCT00797823

Last Updated: 2011-10-07

Results Overview

Effectiveness of closed loop diabetes control will be measured by mean glucose.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2011-10-07

Participant Flow

Patients were recruited from the Oregon Health and Science University (OHSU) outpatient clinics in Portland, Oregon.

A total of 22 studies in 14 subjects were performed. 6 subjects participated in 7 9-hour pilot studies, 6 with insulin and glucagon and 1 with insulin + placebo to assess the safety of the protocol. 8 subjects then underwent 2 interventional studies each for a total of 16 studies, one with insulin and placebo and one with insulin and glucagon.

Participant milestones

Measure	Insulin + Glucagon -> Insulin + Placebo) This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Insulin + Placebo -> Insulin + Glucagon This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Pilot Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
Pilot Studies STARTED	0	0	6
Pilot Studies COMPLETED	0	0	6
Pilot Studies NOT COMPLETED	0	0	0
First Period (Initial Randomization) STARTED	4	4	0
First Period (Initial Randomization) COMPLETED	3	4	0
First Period (Initial Randomization) NOT COMPLETED	1	0	0
Second Period (Crossover) STARTED	3	4	0
Second Period (Crossover) COMPLETED	3	4	0
Second Period (Crossover) NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Insulin + Glucagon -> Insulin + Placebo) This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Insulin + Placebo -> Insulin + Glucagon This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Pilot Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
First Period (Initial Randomization) Physician Decision	1	0	0

Baseline Characteristics

Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

Baseline characteristics by cohort

Measure	Insulin + Glucagon -> Insulin + Placebo) n=4 Participants This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Insulin + Placebo -> Insulin + Glucagon n=4 Participants This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Pilot n=6 Participants Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	14 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	33.3 years STANDARD_DEVIATION 10.5 • n=93 Participants	39.8 years STANDARD_DEVIATION 10.7 • n=4 Participants	35.1 years STANDARD_DEVIATION 17.4 • n=27 Participants	36.7 years STANDARD_DEVIATION 13.7 • n=483 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants
Region of Enrollment United States	4 participants n=93 Participants	4 participants n=4 Participants	6 participants n=27 Participants	14 participants n=483 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The number of participants for analysis was determined was per protocol.

Effectiveness of closed loop diabetes control will be measured by mean glucose.

Outcome measures

Measure	Placebo Comparator: Insulin Alone n=8 Participants No glucagon given during closed loop control-insulin only	Active Comparator: Insulin Plus Glucagon n=13 Participants Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
Effectiveness of Closed Loop Diabetes Control	136.9 mg/dl Standard Error 5.0	149.5 mg/dl Standard Error 5.5

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Placebo Comparator: Insulin Alone n=8 Participants No glucagon given during closed loop control-insulin only	Active Comparator: Insulin Plus Glucagon n=13 Participants Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
Percent of Time Venous Blood Glucose <70 mg/dl	2.8 percent of time Standard Error 0.67	1.15 percent of time Standard Error 0.41

Adverse Events

Insulin + Glucagon -> Insulin + Placebo)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Insulin + Placebo -> Insulin + Glucagon

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Pilot

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin + Glucagon -> Insulin + Placebo) n=4 participants at risk This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Insulin + Placebo -> Insulin + Glucagon n=4 participants at risk This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).	Pilot n=6 participants at risk Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
Endocrine disorders Severe Hypoglycemia	100.0% 4/4 • Number of events 55 • Over 1 year for entire research period, and over the study period for each individual study.	100.0% 4/4 • Number of events 67 • Over 1 year for entire research period, and over the study period for each individual study.	16.7% 1/6 • Number of events 1 • Over 1 year for entire research period, and over the study period for each individual study.
Gastrointestinal disorders Nausea and vomiting	25.0% 1/4 • Number of events 1 • Over 1 year for entire research period, and over the study period for each individual study.	0.00% 0/4 • Over 1 year for entire research period, and over the study period for each individual study.	0.00% 0/6 • Over 1 year for entire research period, and over the study period for each individual study.

Additional Information

W Kenneth Ward MD

Legacy Health System

Phone: 503-413-5171

Email: wardk@ohsu.edu

Results disclosure agreements

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