Evaluation of the Efficacy and Safety of DBL-4pen Mobile Application in Patients With Type 2 Diabetes

This study conducted in 40 adults living with type 2 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.After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection), the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps, in addition to the Dexcom G6 CGM. An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application.The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes.Data related to efficacy of DBL-4pen, global safety of DBL-4pen, compliance with recommended insulin injections, satisfaction with the system and quality of life will be collected.The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

Inclusion criteria:Device-related inclusion criteria:Patients under basal-bolus scheme for type 2 diabetesPatients aged ≥ 18 years oldPatients using rapid-acting analog and long-acting analog that are compatible with Mallya cap (Lispro, Detemir, Aspart, Glargine, Glulisine) with a stable insulin therapy regimen for at least the past 90 days (no modification of the number of injections and no more than 10% variation of the total daily dose)Patients using insulin with a concentration 100 U/mLStudy-specific inclusion criteria:No significant modification of diabetes treatment during the 3 months before inclusion (i.e., no introduction or removal of any pharmacological treatment, and no education training during this period), except for a possible modification for an equivalent insulin compatible with Mallya at least 15 days before inclusionPatients having an HbA1c ≤ 10%Patients who agree to use Dexcom G6 as CGMPatients living in an area covered by phone networkPatients must be affiliated to any kind of social securityPatients must be able to speak and be literate in FrenchNon-isolated patients, not living alone, or having a "resource" person living nearby and having a telephone and the key of his homeHaving signed the free and informed consent formSubject equipped with a CGM for at least the past 90 daysNon-inclusion criteriaDevice-related non-inclusion criteriaPatients with Total Daily Dose (TDD) < 10 UPatients 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).Patients with severe uncorrected hearing impairment and/or severe uncorrected proble- ms of visual acuity.Patients unable to understand and perform instructions provided by Diabeloop SA.Patients who are unwilling or unable to maintain contact with the healthcare professional.Use of any insulin that is not 100U/mL rapid-acting insulin analog, 100U/mL long-acting insulin analog.Study-specific non-inclusion criteria:Patients with type 1 diabetesPatients not feeling hypoglycemia (hypoglycemia unawareness)Patients who had an episode of severe hypoglycemia or a hypoglycemic coma in the past year while being equipped with any glucose sensorPatients not accepting to stay in France during the studyPregnant woman (verified by urine HCG pregnancy test for any woman wishing to participate in the protocol and of childbearing age < 60 year) 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 studySubjects under legal protection (guardianship, curatorship)Patients whose pancreas has been removed or is not functioning altogetherPatients with islet/pancreas transplants.Patients with severely altered renal function (creatinine clearance <30 mL/min).Patients on dialysisCritically ill patientsAny 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.