DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump Trial

Launched by DIABELOOP · Nov 24, 2022

Keywords

ClinConnect Summary

This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.

The study periods are as follows:

* 2 weeks of baseline period at home will be performed. During this baseline period, all patients will use their current therapy: MDI or competitor open-loop pump. In addition to their standard treatment, all patients will receive a Dexcom G6 coupled with the DBLG1 handset used exclusively to collect the data
* Followed by a 6 weeks ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject who is at least 18 years old,
• • 2. The total daily dose required must be less than 90 units (U),
• • 3. Subject accepting to be treated with 100 U/mL rapid-acting insulin analog,
• • 4. Type 1 diabetes treated for at least 6 months (Patients treated by manual injection with insulin pen - MDI - or by competitor open loop systems or former closed loop patients if they stopped the closed loop system \> 3 months before inclusion) with a stable insulin therapy regimen for at least 15 days,
• • 5. HbA1c ≤ 10%,
• • 6. Subject must be affiliated to any kind of social security,
• • 7. Living in an area covered by a GSM (Global System for Mobile Communications) network,
• • 8. Non-isolated patient, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home,
• • 9. Must be able to speak and be literate in French,
• • 10. Having signed the free and informed consent form
• Exclusion Criteria:
• • 1. Subject receiving a total daily dose of insulin below 8 U,
• • 2. Subject suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids),
• • 3. Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity,
• • 4. Subject unable to understand and perform instructions provided by Diabeloop SA,
• • 5. Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period,
• • 6. Subject who is unwilling or unable to maintain contact with the healthcare professional,
• • 7. Subject using a pacemaker. There is the risk of this device adversely affecting pacemakers and causing them to malfunction,
• • 8. Subject is unable to tolerate tape adhesive around the sensor or pump placements,
• • 9. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection),
• • 10. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of inclusion visit, or plans to take any oral, injectable, or IV steroids during the study,
• • 11. Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks,
• • 12. Subject is using DPP-4 inhibitor, GLP-1 agonists, metformin, α-glucosidase inhibitors, thiazolidinediones and/or other SGLT2 inhibitors at time of screening,
• • 13. Diagnosed with chronic kidney disease (glomerular filtration \< 30 mL/min or Serum creatinine \> 176 µmol/L),
• • 14. Patient who has had a pancreatectomy or who has pancreatic malfunctions or pancreatic islet transplantation or pancreas transplantation,
• • 15. Patient on dialysis,
• • 16. Patient with impaired hepatic functions,
• • 17. Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator,
• • 18. Pregnant woman or woman of childbearing potential in the absence of an effective method of contraception or if she does not agree to continue using contraception for the duration of the study,
• • 19. Patient under legal protection (curatorship)