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Diabeloop for Highly Unstable Type 1 Diabetes | Clinical Trials | Clareo Health

COMPLETEDNA

Diabeloop for Highly Unstable Type 1 Diabetes

In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study

NCT04042207•Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

View on ClinicalTrials.gov

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).

Eligibility

Age

22 - No limit years

Sex

ALL

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%
+3 more criteria

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
+9 more criteria

Locations (2)

Grenoble Alpes University Hospital

Grenoble, France

Lille University Hospital

Lille, France

Key Dates

Start Date

September 3, 2019

Primary Completion Date

February 27, 2020

Completion Date

March 22, 2021

Last Updated

May 10, 2021

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, BrittleClosed-Loop

Interventions

Low Glucose Predictive Suspend system

DEVICE

DBLHU System

DEVICE

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

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RECRUITINGNA

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

NCT06748963

Diabetes Mellitus, Type 1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Diabeloop for Highly Unstable Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Closed Loop and Education for Hypoglycemia Awareness Restoration

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes