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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

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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

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Treatement by Insulin Pump Device: HYBRID Device: OPEN Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes
Study Start Date : May 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Low Blood Glucose Index (LBGI) [ Time Frame: for each period of 2 month (hybrid period and open period) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153190


Locations
France
CHU Montpellier
Montpellier, France, 34000
Italy
University of Padova
Padova, Italy
Netherlands
University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Eric ER RENARD, MD University Hospital, Montpellier

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02153190     History of Changes
Other Study ID Numbers: 8628 4
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015

Keywords provided by University Hospital, Montpellier:
Type 1 Diabetes,
T1DM,
Artificial Pancreas

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
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents