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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

Primary Purpose

Type 1 Diabetes Mellitus, Treatement by Insulin Pump

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HYBRID

OPEN

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes,, T1DM,, Artificial Pancreas

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 et < 70 years old
Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
BMI < 35 kg/m²
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
Trained in carbohydrate counting
HbA1c > 7.5 % and < 10%
If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
Willing to undergo all study procedures
Informed consent signed

Exclusion criteria:

Pregnancy or breast feeding, or intention to be pregnant during the study duration
Use of a medication that significantly impacts glucose metabolism, e.g. steroids
Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
Patient plans to go abroad during the trial period
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
Patient does not hold any nearby party for assistance if needed
Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
Presence of any malignant disease, unless considered as cured for more than 10 years
History of acute cardiovascular event during the prior year
History of diabetic keto-acidosis during the prior 6 months
Renal insufficiency with creatinin > 150 μmol/L
Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
Impaired cognitive or psychological abilities which may result in defective adherence to study conditions

Sites / Locations

CHU Montpellier
University of Padova
University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HYBRID-OPEN

OPEN-HYBRID

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period

Secondary Outcome Measures

Low Blood Glucose Index (LBGI)

Full Information

NCT ID

NCT02153190

First Posted

May 29, 2014

Last Updated

November 5, 2015

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02153190

Brief Title

Hybrid Artificial Pancreas in Home Setting

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus, Treatement by Insulin Pump

Keywords

Type 1 Diabetes,, T1DM,, Artificial Pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HYBRID-OPEN

Arm Type

Experimental

Arm Description

Arm Title

OPEN-HYBRID

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

HYBRID

Intervention Description

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

Intervention Name(s)

OPEN

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

Low Blood Glucose Index (LBGI)

Time Frame

for each period of 2 month (hybrid period and open period)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 et < 70 years old Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria Under basal-bolus insulin therapy using an external insulin pump for at least 3 months BMI < 35 kg/m² 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 Trained in carbohydrate counting HbA1c > 7.5 % and < 10% If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion Willing to undergo all study procedures Informed consent signed Exclusion criteria: Pregnancy or breast feeding, or intention to be pregnant during the study duration Use of a medication that significantly impacts glucose metabolism, e.g. steroids Uncontrolled hypertension with resting blood pressure over 140/90 mmHg Patient plans to go abroad during the trial period 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 Patient does not hold any nearby party for assistance if needed Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year. Presence of any malignant disease, unless considered as cured for more than 10 years History of acute cardiovascular event during the prior year History of diabetic keto-acidosis during the prior 6 months Renal insufficiency with creatinin > 150 μmol/L Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values Impaired cognitive or psychological abilities which may result in defective adherence to study conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric ER RENARD, MD

Organizational Affiliation

University Hospital, Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Montpellier

City

Montpellier

ZIP/Postal Code

34000

Country

France

Facility Name

University of Padova

City

Padova

Country

Italy

Facility Name

University of Amsterdam

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

27208331

Citation

Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

Results Reference

derived

PubMed Identifier

26432775

Citation

Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.

Results Reference

derived

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Hybrid Artificial Pancreas in Home Setting

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