NCT04042207 (DBLHU) is a NA clinical trial of Low Glucose Predictive Suspend system in Diabetes Mellitus, Type 1, sponsored by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète.

What drugs are being tested in NCT04042207?

Interventions in NCT04042207: Low Glucose Predictive Suspend system, DBLHU System.

What condition does NCT04042207 study?

NCT04042207 studies Diabetes Mellitus, Type 1, Diabetes Mellitus, Brittle, Closed-Loop.

Is NCT04042207 still recruiting?

NCT04042207 is currently completed. Last updated 10 May 2021.

Last reviewed 2021-05-10 · How we verify

NCT04042207: DBLHU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Diabeloop for Highly Unstable Type 1 Diabetes

Completed NA Last updated 10 May 2021

What this trial tests

NA trial testing Low Glucose Predictive Suspend system in Diabetes Mellitus, Type 1 in 7 participants. Completed in 22 March 2021.

Timeline

3 September 2019

Primary endpoint
27 February 2020

22 March 2021

Quick facts

Lead sponsor	Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	device feasibility
Enrollment	7
Start date	3 September 2019
Primary completion	27 February 2020
Estimated completion	22 March 2021
Sites	2 locations across France

Drugs / interventions tested

Low Glucose Predictive Suspend system
DBLHU System

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Diabetes Mellitus, Brittle — all drugs for Diabetes Mellitus, Brittle →
Closed-Loop — all drugs for Closed-Loop →

Sponsor

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

Who can join

22 and older, any sex, with Diabetes Mellitus, Type 1 or Diabetes Mellitus, Brittle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

2020 Diabetes Technology Meeting Abstracts
· 2021

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

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NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

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

Trials by the same sponsor.

NCT06896045 — Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With T · NA · recruiting
NCT05567692 — Subjects With T2D or at Risk of T2D Cohort Follow-up · active not recruiting
NCT04725591 — Diabeloop for Teens · NA · completed
NCT06365255 — National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes · completed
NCT04537520 — Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04042207 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Last refreshed: 10 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04042207.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing