Observational Study of the Use of DBLG1 System in Real Life

NCT04749693 | Recruiting

• 1 other identifier: RCB 2020-A 02808-31
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 20

Brief Summary

This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician. Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison. The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

Conditions

Type1diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• time in 70 - 180 mg/dL glycemic range

  Improvement of the time in glycemic range 70 - 180 mg/dL, in percentage, on 24hours and nighttime

  through study completion, an average of 1 year

Secondary Outcomes (13)

• HbA1c HbA1c HbA1c

  at the beginning and at the end of the study (1 year between each value)

• mean CGM

  through study completion, an average of 1 year

• time in 70 - 140 mg/dL glycemic range

  through study completion, an average of 1 year

• time in hypoglycemia

  through study completion, an average of 1 year

• time in hyperglycemia

  through study completion, an average of 1 year

Study Arms (1)

Patient with HbA1c >= 8% despite the use of insulin pump and frequent glycemic control

only group included in the study

Device: DBLG1 System

Interventions

DBLG1 System DEVICE

Use of DBLG1 System in real life condition

Patient with HbA1c >= 8% despite the use of insulin pump and frequent glycemic control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with type 1 diabetes equal or more than 18 years old, with Hb1Ac ≥ 8%

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Diabeloop: lead

Study Sites (20)

Hôpital Avicenne APHP

Bobigny, 93000, France

NOT YET RECRUITING

Hôpital de la cavale blanche

Brest, 29200, France

NOT YET RECRUITING

CHU Caen

Caen, 14000, France

RECRUITING

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

NOT YET RECRUITING

CHU Bocage Central

Dijon, 21079, France

RECRUITING

Hôpital Simone Veil

Eaubonne, 95600, France

NOT YET RECRUITING

CHU Grenoble

Grenoble, 38000, France

RECRUITING

Groupe Hospitalier La Rochelle - Ré - Aunis

La Rochelle, 17019, France

RECRUITING

CHU Lille

Lille, 59037, France

NOT YET RECRUITING

Diab-e-Care

Lyon, 69008, France

NOT YET RECRUITING

Hôpital Européen

Marseille, 13003, France

NOT YET RECRUITING

Hôpital la conception, pole ENDO

Marseille, 13385, France

NOT YET RECRUITING

hôpital Nord Laennec

Nantes, 44093, France

RECRUITING

Lariboisière - Fernand Widal APHP

Paris, 75010, France

NOT YET RECRUITING

Hôpital Bichet Claude Bernard - APHP

Paris, 75018, France

NOT YET RECRUITING

Clinique Princess

Pau, 64000, France

NOT YET RECRUITING

CHU Reims

Reims, 51100, France

RECRUITING

Hôpital Pontchaillou

Rennes, 35000, France

RECRUITING

Hôpital civil de Strasbourg

Strasbourg, 67000, France

RECRUITING

Hôpital de Rangueil

Toulouse, 31400, France

NOT YET RECRUITING

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

• Pauline Schaepelynck

  APHM Hôpital Sud Sainte Marguerite

  PRINCIPAL INVESTIGATOR

• Lucy Chaillous

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Hélène Hanaire

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Sandrine Lablanche

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Alfred Penfornis

  CH Sud Francilien

  PRINCIPAL INVESTIGATOR

• Yves Reznik

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Chassouant

CONTACT

0767417660; clinical-trial@diabeloop.fr

Erik Huneker

CONTACT

erik@diabeloop.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 11, 2021
• Study Start: May 17, 2021
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)