Diabeloop for Highly Unstable Type 1 Diabetes

NCT04042207 | Completed

• 1 other identifier: 2019-A01365-52
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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

Keywords

Artificial pancreas; Very Unstable Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods for the third and fourth week for each treatment period

  Measured by continuous glucose monitoring

  14 days for each treatment period

Secondary Outcomes (16)

• Evolution over time of the DBLHU system's performance on a day-to-day and determination of the optimization delay of glycemic control

  Over twenty-four hour periods on the four weeks of each treatment period and of the 24-week and 48-week extented CL period.

• Percent of CGM time in glucose range 70-180 mg/dl during nighttime.

  Overnight (defined as 00:00 to 06:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

• Percent of CGM time in glucose range 70-180 mg/dl during daytime.

  Over daytime (defined as 06:00 to 00:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

• Percent of CGM time with glucose < 70mg/dl, < 60mg/dl, < 54mg/dl and < 50mg/dl

  Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

• Percent of CGM time with glucose > 180mg/dl, > 250mg/dl, > 300mg/dl and > 360mg/dl

  Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.

Study Arms (2)

Reference treatment (Open-Loop)

ACTIVE COMPARATOR

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

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

DBLHU system (Closed-Loop)

EXPERIMENTAL

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

Device: DBLHU System

Interventions

Low Glucose Predictive Suspend system DEVICE

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

Also known as: Open-loop condition

Reference treatment (Open-Loop)

DBLHU System 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.

Also known as: Closed-loop condition

DBLHU system (Closed-Loop); Reference treatment (Open-Loop)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Grenoble Alpes University Hospital

Grenoble, 38700, France

Location

Lille University Hospital

Lille, 59037, France

Location

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

• Pierre Yves BENHAMOU, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N-of-1 trials consists in a prospectively planned, multiple crossover study in a single individual.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 1, 2019
• Study Start: September 3, 2019
• Primary Completion: February 27, 2020
• Study Completion: March 22, 2021
• Last Updated: May 10, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)