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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

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: NCT02153190
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period [ Time Frame: during 2 months-hybrid period and during 2 months-open period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02153190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Low Blood Glucose Index (LBGI) [ Time Frame: for each period of 2 month (hybrid period and open period) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hybrid Artificial Pancreas in Home Setting
Official Title  ICMJE Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes
Brief Summary The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients
Detailed Description During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Treatement by Insulin Pump
Intervention  ICMJE
  • Device: HYBRID
    During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
  • Device: OPEN
    During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
Study Arms  ICMJE
  • Experimental: HYBRID-OPEN

    Patients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.

    During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

    Interventions:
    • Device: HYBRID
    • Device: OPEN
  • Experimental: OPEN-HYBRID

    Patients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

    During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

    Interventions:
    • Device: HYBRID
    • Device: OPEN
Publications *

*   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: May 30, 2014)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 et < 70 years old
  2. Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
  3. Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
  4. BMI < 35 kg/m²
  5. Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
  6. Trained in carbohydrate counting
  7. HbA1c > 7.5 % and < 10%
  8. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
  9. Willing to undergo all study procedures
  10. Informed consent signed

Exclusion criteria:

  1. Pregnancy or breast feeding, or intention to be pregnant during the study duration
  2. Use of a medication that significantly impacts glucose metabolism, e.g. steroids
  3. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  4. Patient plans to go abroad during the trial period
  5. Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
  6. Patient does not hold any nearby party for assistance if needed
  7. Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
  8. Presence of any malignant disease, unless considered as cured for more than 10 years
  9. History of acute cardiovascular event during the prior year
  10. History of diabetic keto-acidosis during the prior 6 months
  11. Renal insufficiency with creatinin > 150 μmol/L
  12. Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
  13. Impaired cognitive or psychological abilities which may result in defective adherence to study conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153190
Other Study ID Numbers  ICMJE 8628 4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric ER RENARD, MD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date November 2015

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