Observational Study of the Use of DBLG1 System in Real Life

Launched by DIABELOOP · Feb 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of the DBLG1 System, a medical device designed to help people with Type 1 diabetes manage their blood sugar levels in real-life situations. The study will include adult patients aged 18 and older who have been using an insulin pump for at least six months but still have higher than desired blood sugar levels. To participate, patients must also be using a specific type of fast-acting insulin and check their blood sugar several times a day.

Participants in the study will continue their usual diabetes care and will have regular check-ups with their healthcare providers. Over one year, researchers will collect information about their blood sugar levels, any diabetes-related complications, and their quality of life. This data will be compared to the participant's blood sugar levels from a short period before they start using the DBLG1 System. At the end of the study, participants will keep using the DBLG1 System as part of their regular diabetes management. This study is currently looking for volunteers, and it is important for potential participants to understand they must be willing to follow the guidelines for using the system throughout the study.

Gender

ALL

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)