Hybrid Artificial Pancreas in Home Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Treatement by Insulin Pump

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HYBRID

Intervention Type DEVICE

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.

OPEN

Intervention Type DEVICE

During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

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.

Group Type EXPERIMENTAL

HYBRID

Intervention Type DEVICE

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.

OPEN

Intervention Type DEVICE

During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No