Trial Outcomes & Findings for Real-time Adaptation to Changes in Insulin Sensitivity (NCT NCT01261052)

Results Overview

The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

all 33 hour studies

Results posted on

2012-12-03

Participant Flow

Subjects were recruited from the Greater Portland Oregon area and screened from Oct 2010 through January 2011 at a Legacy Health system clinic facility.

Each of the 14 subjects will participate in two artificial pancrease glucose control study interventions.

Participant milestones

Participant milestones
Measure	All Study Participants Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
FMPD/APD Intervention (33 Hours) STARTED	14
FMPD/APD Intervention (33 Hours) COMPLETED	14
FMPD/APD Intervention (33 Hours) NOT COMPLETED	0
APD Only Intervention (33 Hours) STARTED	14
APD Only Intervention (33 Hours) COMPLETED	14
APD Only Intervention (33 Hours) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real-time Adaptation to Changes in Insulin Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=14 Participants Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	46.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: all 33 hour studies

Population: The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment

The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.

Outcome measures

Outcome measures
Measure	All Study Participants n=14 Participants Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity APD intervention	176 mg/dl Standard Deviation 64
Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity FMPD intervention	195 mg/dl Standard Deviation 69

SECONDARY outcome

Timeframe: all 33 hour studies

Population: The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment

Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).

Outcome measures

Outcome measures
Measure	All Study Participants n=14 Participants Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity. APD intervention	199 mg/dl Standard Deviation 65
Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity. FMPD/APD intervention	218 mg/dl Standard Deviation 74

Adverse Events

APD Only Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

FMPD/APD Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	APD Only Intervention n=14 participants at risk The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.	FMPD/APD Intervention n=14 participants at risk The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.
General disorders upper extremity pain	7.1% 1/14 • Number of events 1 • Adverse event data was collected for 6 months.	0.00% 0/14 • Adverse event data was collected for 6 months.

Additional Information

Dr. W Kenneth Ward

Legacy Health System

Phone: 503-413-5171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place