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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01973413
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : August 15, 2014
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Marc Breton, University of Virginia

Tracking Information
First Submitted Date  ICMJE October 24, 2013
First Posted Date  ICMJE October 31, 2013
Results First Submitted Date  ICMJE June 27, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
Percent Time Near Normoglycemia [ Time Frame: 6 nights ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Percent of values in a glucose target range of 70-150 mg/dl [ Time Frame: 2 overnights (~16 hours) ]
The Diabetes Assistant (DiAs)system will run in closed-loop closed-to-range (CTR) mode overnight
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Overnight Glucose [ Time Frame: 6 nights ]
    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 ]
    Number of nights with >= 1 hypo- and hyperglycemic event 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
Official Title  ICMJE Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Diabetes Assistant (DiAs)
    • Device: Tandem t:slim Insulin Pump
    • Device: Dexcom G4 Platinum sensor
  • 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.
    Interventions:
    • Device: Tandem t:slim Insulin Pump
    • Device: Dexcom G4 Platinum sensor
Publications * Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2014)
32
Original Actual Enrollment  ICMJE
 (submitted: October 24, 2013)
12
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973413
Other Study ID Numbers  ICMJE 001-Stanford
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Breton, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Stanford University
Investigators  ICMJE
Principal Investigator: Bruce Buckingham, MD Stanford University
Principal Investigator: Marc Breton, PhD University of Virginia Center for Diabetes Technology
PRS Account University of Virginia
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP