Diabeloop for Highly Unstable Type 1 Diabetes

NCT ID: NCT04042207

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-03-22

Brief Summary

Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.

A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.

An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Brittle; Closed-Loop

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Reference treatment (Open-Loop)

Sensor-augmented pump therapy (SAP) namely the Low Glucose Predictive Suspend system or LGPS and a blinded glucose sensor (Dexcom G6) followed by a 48-week extension period in closed-loop condition

Group Type: ACTIVE_COMPARATOR

Low Glucose Predictive Suspend system

Intervention Type: DEVICE

consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)

DBLHU System

Intervention Type: DEVICE

DBLHU system embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

DBLHU system (Closed-Loop)

DBLHU software (a Model Predictive Control \[MPC\]-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleido insulin pump followed by a 48-week extension period in closed-loop condition

Group Type: EXPERIMENTAL

DBLHU System

Intervention Type: DEVICE

DBLHU system embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

Interventions

Low Glucose Predictive Suspend system

consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)

Intervention Type: DEVICE

DBLHU System

DBLHU system embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

Intervention Type: DEVICE

Other Intervention Names

Open-loop condition; Closed-loop condition

Eligibility Criteria

Inclusion Criteria

• Subject (aged 22 or more) with Type 1 diabetes for at least 5 years and confirmed C peptide negative
• Treated with continuous subcutaneous insulin infusion (CSII) for ≥ 6 months,
• Trained to carbohydrate counting/flexible insulin therapy,
• Subject that had experienced, despite optimal diabetes management and prior to any equipment with Smartguard technology, glucose instability as defined by at least 2 of the following criteria which would have led to eligibility for pancreatic islet transplantation:

• occurrence of at least 1 severe hypoglycemic episode during the past 12 months (need for third party),
• occurrence of ketoacidosis (hospitalization in ICU) without explanation
• Impaired awareness of hypoglycemia (Clark Score ≥ 4; Gold Score > 4)
• glucose levels: standard deviation > 50% of the arithmetic mean value on glucose meter or > 40 mg/dl on CGM on a 14-day recording
• glucose levels: MAGE (mean amplitude of glucose excursions) index > 60 mg/dl
• glucose levels: coefficient of variation (CV) > 36%
• with persisting extreme glucose variability despite optimal medical care
• with contra-indication or no agreement to undertake pancreatic islet transplantation or pancreas transplantation.
• Subject willing to wear the DBLHU system continuously throughout the study

Exclusion Criteria

• patient with type 2 diabetes
• age < 22 years old
• patient without any social or familial support able to intervene in case of severe hypoglycemic event
• any permanent and severe condition able to interact with the normal course of the study
• patient with insulin-resistance defined by insulin requirements > 1.5U/kg/d
• patient with a daily dose of insulin required greater than 90 units
• patient receiving a total daily dose of insulin less than 8 U
• use of any insulin that is not 100 U/mL fast-acting insulin analog
• patient suffering from a serious illness or a treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment of steroids)
• patient having severe problems of uncorrected hearing and/or visual acuity
• patient who is unable to understand and perform all the instructions provided by Diabeloop SA
• patient not willing to perform ≥4 finger stick blood glucose measurements daily
• patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
• patient who has had a pancreatectomy or who has pancreatic malfunctions
• patient having severely altered renal function (Creatinine clearance < 30ml/min)
• patient on dialysis
• pregnancy or breast-feeding patient, or project of pregnancy during the next 6 months
• lack of effective contraception in women of childbearing potential
• all conditions excluding participation to clinical research as defined in France

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Yves BENHAMOU, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble Alpes University Hospital

Grenoble, , France

Lille University Hospital

Lille, , France

Countries

France

Other Identifiers

2019-A01365-52

Identifier Type: -

Identifier Source: org_study_id