Hybrid Artificial Pancreas in Home Setting

NCT02153190 | Completed Phase 2

• 1 other identifier: 8628 4
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 3

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

Conditions

Type 1 Diabetes Mellitus; Treatement by Insulin Pump

Keywords

Type 1 Diabetes,; T1DM,; Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Low Blood Glucose Index (LBGI)

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

Study Arms (2)

HYBRID-OPEN

EXPERIMENTAL

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; Device: OPEN

OPEN-HYBRID

EXPERIMENTAL

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; Device: OPEN

Interventions

HYBRID 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.

HYBRID-OPEN; OPEN-HYBRID

OPEN DEVICE

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

HYBRID-OPEN; OPEN-HYBRID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• Willing to undergo all study procedures
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

CHU Montpellier

Montpellier, 34000, France

Location

University of Padova

Padua, Italy

Location

University of Amsterdam

Amsterdam, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 27208331 DERIVED

• 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.

  PMID: 26432775 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric ER RENARD, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

IT (1); FR (1); NL (1)