Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

November 5, 2015 updated by: University Hospital, Montpellier

Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • CHU Montpellier
  • Italy
      • Padova, Italy
        • University of Padova
  • Netherlands
      • Amsterdam, Netherlands
        • University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during 2 months-hybrid period and during 2 months-open period

Secondary Outcome Measures

Outcome Measure
Time Frame
Low Blood Glucose Index (LBGI)
Time Frame: for each period of 2 month (hybrid period and open period)
for each period of 2 month (hybrid period and open period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Eric ER RENARD, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8628 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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