Observational use of the DBLG1 system for managing Type 1 diabetes

Observational Study of the Use of DBLG1 System in Real Life

This study is testing how well the DBLG1 closed-loop insulin delivery system helps people with Type 1 diabetes manage their condition in everyday life over a year.

Quick facts

• Study type: Observational
• Enrollment: 348 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Diabeloop (Industry-sponsored)
• Locations: 20 sites (Bobigny and 19 other locations)
• Trial ID: NCT04749693 on ClinicalTrials.gov

What this trial studies

This observational study involves Type 1 diabetes patients using the DBLG1 System, a closed-loop insulin delivery device, in real-life settings across multiple centers in France. Participants will maintain their usual diabetes care while their glycemic data, complications, and quality of life will be monitored over one year. The study aims to gather comprehensive data to evaluate the effectiveness of the device compared to a two-week run-in period without the loop mode. A total of 348 patients will be included, with data collection occurring through regular clinician visits and questionnaires.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Type 1 diabetes, an HbA1c level of 8% or higher, and a total daily insulin dose of less than 90 units.

Not a fit: Patients with serious illnesses or those on treatments that significantly impair diabetes physiology may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve glycemic control and quality of life for patients with Type 1 diabetes using the DBLG1 system.

How similar studies have performed: Previous studies on closed-loop insulin delivery systems have shown promising results, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* patients with type 1 diabetes;
* patients who are at least 18 years old;
* patients total daily dose required must be less than 90 units (U);
* patients accepting to be treated with 100 U/mL rapid-acting insulin analog
* patients having a HbA1c ≥ 8% despite of the use of a pump for at least 6 months
* patients performing glucose self-monitoring several times ( ≥ 4) a day
* patient accepting the technology
* patients agreeing to use the system with activated loop mode during at least 75% of the
* total time of use, this will be analyzed after 1 year of use.
* patients must be affiliated to any kind of social security

Exclusion Criteria:

* patients receiving a total daily dose of insulin lower than 8 U;
* patients suffering from a serious illness or having a treatment that might significantly impair diabetes physiology (iSGLT2, steroids, metformin), i.e. glucose-insulin interactions, that might interfere with the medical device (for example treatment by steroids with variable dosage during the study period);
* patients having severe uncorrected problems of hearing and/or visual acuity preventing proper use of DBLG1 System;
* patients unable to understand and perform all of the instructions regarding the devices and the clinical investigation provided by Diabeloop.
* patients planning to perform during the year of study repeated magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The G6 has not been tested in those situations. The magnetic fields and heat could damage the components of the Dexcom G6, which may cause it to display inaccurate sensor glucose readings (readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, patients might be exposed to severe low or high glucose events;
* patients who are unwilling or unable to maintain contact with the healthcare professional;
* patients willing to use any insulin that is not 100 U/mL rapid-acting insulin analog with the system (for example regular insulin; long-acting insulin analog; 200 U/mL rapid-acting insulin analog)

Where this trial is running

Bobigny and 19 other locations

• Hôpital Avicenne APHP — Bobigny, France (Not_yet_recruiting)
• Hôpital de la cavale blanche — Brest, France (Not_yet_recruiting)
• CHU Caen — Caen, France (Recruiting)
• Centre Hospitalier Sud Francilien — Corbeil-Essonnes, France (Not_yet_recruiting)
• CHU Bocage Central — Dijon, France (Recruiting)
• Hôpital Simone Veil — Eaubonne, France (Not_yet_recruiting)
• CHU Grenoble — Grenoble, France (Recruiting)
• Groupe Hospitalier La Rochelle - Ré - Aunis — La Rochelle, France (Recruiting)
• CHU Lille — Lille, France (Not_yet_recruiting)
• Diab-e-Care — Lyon, France (Not_yet_recruiting)
• Hôpital Européen — Marseille, France (Not_yet_recruiting)
• Hôpital la conception, pole ENDO — Marseille, France (Not_yet_recruiting)
• hôpital Nord Laennec — Nantes, France (Recruiting)
• Lariboisière - Fernand Widal APHP — Paris, France (Not_yet_recruiting)
• Hôpital Bichet Claude Bernard - APHP — Paris, France (Not_yet_recruiting)
• Clinique Princess — Pau, France (Not_yet_recruiting)
• CHU Reims — Reims, France (Recruiting)
• Hôpital Pontchaillou — Rennes, France (Recruiting)
• Hôpital civil de Strasbourg — Strasbourg, France (Recruiting)
• Hôpital de Rangueil — Toulouse, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Pauline Schaepelynck — APHM Hôpital Sud Sainte Marguerite
• Study coordinator: Marion Chassouant

Conditions Type1diabetes; Type 1 Diabetes; HbA1c > 8%; Closed loop system; insulin pump; Algorithm; Real life