Observational Study of the Use of DBLG1 System in Real Life
Observational Study of the Use of DBLG1 System in Real Life
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).
The study is designed to address the specific requirements from National Commission for the
 Evaluation of Medical Devices and Health Technologies (CNEDiMTS) and to complete data
 obtained up to now, with a larger cohort and in real life settings.

 In order to increase variability in the profiles of patients included and to be as
 representative as possible of all eligible patients, 20 centers will participate in the
 study, both private and public, with a mix of university and regional centers and 348
 patients will be included consecutively.

 The inclusion period lasts 6 months and each patient will be included in the study for a
 period of 2 weeks of run-in and 1 year of treatment. An inclusion period of 6 months is
 enough according to investigation site data and estimation of inclusion over 6 months
 (detailed in part Healthcare professional and investigation centers recruitment).

 This study is observational. Patients included follow their usual medical care and will only
 be asked for the specific need of the study to answer two questionnaires (at the beginning
 and at the end of the study) and give their HbA1c results performed in their current medical
 follow-up. As it is a post-registration study, medical devices are provided to patients on
 medical prescription by healthcare providers, which have signed a distribution agreement with
 and have been trained by Diabeloop. Patients have their system for 4 a maximum of 4 years
 (life duration of the medical device (DBLG1 System)).

 Patients follow-up visits are not mandatory and no frequency is imposed. Investigators,
 according to their habits, have follow-up visits corresponding to what they usually propose
 to patients having a new treatment.

 During the whole study and apart from scheduled visits (inclusion, beginning of run-in,
 beginning of treatment , enf of study), each patient may contact his/her clinician
 investigator in case of issue he/she judges as serious, for questions, etc. In that case, the
 clinician may program a visit with the patient and deal with adverse events. Phone calls are
 recorded in Case Report Form (CRF), as well as on-site visits.

 Note: with Yourloops; investigators may follow the state of their patients, regarding the
 time in range, mean glycemia value etc. Based on this, they may require a visit at their
 convenience with the patient in order to change parameters of the system, discuss adverse
 events, etc.

 Objectives are the following

 To evaluate improvement in blood glucose control with use of DBLG1 System after one year in
 real life.

 To evaluate details of glycemic control improvement, safety and adverse events due to the
 DBLG1 System, evolution of quality of life after one year in real life and healthcare
 professional support.

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

 HbA1c Mean CGM glucose - on 24hours and nighttime Time in 70 - 140 mg/dL range on 24hours and
 nighttime only Time in hypoglycemia (under 70 mg/dL, 60 mg/dL and 50 mg/dL) - on 24hours and
 nighttime Time in hyperglycemia (above 180 mg/dL, 250 mg/dL and 300 mg/dL) - on 24hours and
 nighttime Percentage of time using activated loop mode vs. deactivated loop mode Standard
 Deviation (SD) and Coefficient of variation (CV) of Continuous Glucose Monitoring (CGM)
 values on 24hours and nighttime Number and type of adverse events Overall and
 diabetic-specific quality of life Quantification of the healthcare professional support
 required
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)