Diabeloop for Highly Unstable Type 1 Diabetes (DBLHU)

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

Status: Completed

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

Treatments: Device: Low Glucose Predictive Suspend system; Device: DBLHU System

Study type: Interventional

Funder types: Other

Identifiers

NCT04042207

2019-A01365-52

Details and patient eligibility

About

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).

Enrollment: 7 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Reference treatment (Open-Loop)

Active Comparator group

Description:

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

Treatment:

Device: DBLHU System

Device: Low Glucose Predictive Suspend system

DBLHU system (Closed-Loop)

Experimental group

Description:

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

Treatment:

Device: DBLHU System