Hybrid Artificial Pancreas in Home Setting

Type 1 Diabetes Mellitus Clinical Trial

— AP Hybrid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153190
• Other study ID #: 8628 4
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2014
• Last updated: November 5, 2015
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Treatement by Insulin Pump
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
Italy	University of Padova	Padova
Netherlands	University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Countries where clinical trial is conducted

France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period		during 2 months-hybrid period and during 2 months-open period	No
Secondary	Low Blood Glucose Index (LBGI)		for each period of 2 month (hybrid period and open period)	No