Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

Brief Summary

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The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

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Detailed Description

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The first phase of this study will test the feasibility of initializing the DiAs CTR system in a clinical research center. We will test the procedures that will occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We will also test how the system performs using the same calibration and blood glucose monitoring that will be done at camp. In the inpatient study we will mimic some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies will be reviewed by the Data Safety Monitoring Board (DSMB) before we proceed with the Phase 2 summer camp studies.

The second phase of this proposal is the "in-camp" studies. The same health care providers that conducted the inpatient studies will be conducting the camp studies. They will be monitoring all campers on closed-loop control in real-time. Participants will be randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Those assigned to DiAs CTR control will be remotely monitored throughout the night. Those assigned to the control group will not have remote monitoring overnight, but they will be wearing a Dexcom G4Platinum sensor with active low and high sensor glucose alarms. Initial studies will be done at a camp with older children and camp staff who are aged 15-35 years of age, with at least 5 subjects between 15 to 18 years old. If these studies are safe (after DSMB review) we will do additional camps and include children 10-14 years old.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed-Loop Control with DiAs System

Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.

Group Type EXPERIMENTAL

Diabetes Assistant (DiAs)

Intervention Type DEVICE

The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.

Tandem t:slim Insulin Pump

Intervention Type DEVICE

FDA, market-approved insulin pump.

Dexcom G4 Platinum sensor

Intervention Type DEVICE

FDA, market-approved continuous glucose monitor (CGM)

Control Group, Sensor-Augmented Pump Therapy

Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.

Group Type PLACEBO_COMPARATOR

Tandem t:slim Insulin Pump

Intervention Type DEVICE

FDA, market-approved insulin pump.

Dexcom G4 Platinum sensor

Intervention Type DEVICE

FDA, market-approved continuous glucose monitor (CGM)

Interventions

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Diabetes Assistant (DiAs)

The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.

Intervention Type DEVICE

Tandem t:slim Insulin Pump

FDA, market-approved insulin pump.

Intervention Type DEVICE

Dexcom G4 Platinum sensor

FDA, market-approved continuous glucose monitor (CGM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months
2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
3. Age 10.0 - 35 years
4. Willingness to use a Sure-T or Contact Detach infusion set while at camp

Exclusion Criteria

1. Diabetic ketoacidosis in the past month
2. Hypoglycemic seizure or loss of consciousness in the past 3 months
3. History of seizure disorder (except for hypoglycemic seizure)
4. Using an OmniPod insulin infusion pump
5. History of any heart disease including coronary artery disease, heart failure, or arrhythmias
6. Cystic fibrosis
7. Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
8. History of ongoing renal disease (other than microalbuminuria).
9. Insulin pump users who supplement with injected intermediate or long acting insulin.
10. Subjects who take other anti-diabetic medications other than insulin..
11. Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
12. Inpatient psychiatric treatment in the past 6 months
13. Uncontrolled adrenal disorder
14. Abuse of alcohol
15. Pregnancy (verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned).
16. Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.

Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No