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RECRUITINGOBSERVATIONAL

Observational Study of the Use of DBLG1 System in Real Life

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DEVICE

DBLG1 System

Use of DBLG1 System in real life condition

Locations (20)

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