Trial record 2 of 14 for:    DIAS 4

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

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Marc Breton, University of Virginia
ClinicalTrials.gov Identifier:
NCT01973413
First received: October 24, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Device: Diabetes Assistant (DiAs)
Device: Tandem t:slim Insulin Pump
Device: Dexcom G4 Platinum sensor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Percent Time Near Normoglycemia [ Time Frame: 6 nights ] [ Designated as safety issue: Yes ]

    Percent of time in a glucose target range of 70-150 mg/dl during camp study.

    Participants were randomized to either closed-loop (experimental) or sensor-augmented pump 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. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.



Secondary Outcome Measures:
  • Overnight Glucose [ Time Frame: 6 nights ] [ Designated as safety issue: No ]

    Mean overnight glucose during camp study.

    Participants were randomized to either closed-loop (experimental) or sensor-augmented pump 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. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.


  • Glycemic Events [ Time Frame: 6 nights ] [ Designated as safety issue: Yes ]

    Number of hypo- and hyperglycemic events occurring overnight during the camp study.

    Participants were randomized to either closed-loop (experimental) or sensor-augmented pump 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. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.



Enrollment: 32
Study Start Date: July 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Device: Tandem t:slim Insulin Pump
FDA, market-approved insulin pump.
Device: Dexcom G4 Platinum sensor
FDA, market-approved continuous glucose monitor (CGM)
Placebo Comparator: 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.
Device: Tandem t:slim Insulin Pump
FDA, market-approved insulin pump.
Device: Dexcom G4 Platinum sensor
FDA, market-approved continuous glucose monitor (CGM)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973413

Locations
United States, California
Stanford University
Los Gatos, California, United States, 95032
Sponsors and Collaborators
University of Virginia
Stanford University
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
Principal Investigator: Marc Breton, PhD University of Virginia Center for Diabetes Technology
  More Information

Publications:
Responsible Party: Marc Breton, Co-Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01973413     History of Changes
Other Study ID Numbers: 001-Stanford
Study First Received: October 24, 2013
Results First Received: June 27, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Virginia:
Artificial Pancreas Project
Diabetes Mellitus, Type 1
Insulin pump therapy
Continuous Glucose Monitors (CGM)
Juvenile-Onset Diabetes
Autoimmune Diabetes
Closed-to-Range
Diabetes Assistant (DiAs)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014