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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
An descriptive interim analysis will be made on the first 100 enrolled patients after 6 months of use of the DBLG1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with HbA1c >= 8% despite the use of insulin pump and frequent glycemic control | only group included in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBLG1 System | Device | Use of DBLG1 System in real life condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| time in 70 - 180 mg/dL glycemic range | Improvement of the time in glycemic range 70 - 180 mg/dL, in percentage, on 24hours and nighttime | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c HbA1c HbA1c | change in the HbA1c after 1 year of use of the device | at the beginning and at the end of the study (1 year between each value) |
| mean CGM | change of mean CGM glucose on 24hours and nighttime |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with type 1 diabetes equal or more than 18 years old, with Hb1Ac ≥ 8%
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Chassouant | Contact | 0767417660 | +33 | clinical-trial@diabeloop.fr |
| Erik Huneker | Contact | erik@diabeloop.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pauline Schaepelynck | APHM Hôpital Sud Sainte Marguerite | Principal Investigator |
| Lucy Chaillous | Nantes University Hospital | Principal Investigator |
| Hélène Hanaire |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne APHP | Not yet recruiting | Bobigny | 93000 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| through study completion, an average of 1 year |
| time in 70 - 140 mg/dL glycemic range | change of time in 70 - 140 mg/dL range on 24hours and nighttime | through study completion, an average of 1 year |
| time in hypoglycemia | change of time in hypoglycemia, under 70 mg/dL, 60 mg/dL and 50 mg/dL on 24hours and nighttime | through study completion, an average of 1 year |
| time in hyperglycemia | change of time in hyperglycemia above 180 mg/dL, 250 mg/dL and 300 mg/dL on 24hours and nighttime | through study completion, an average of 1 year |
| use of loop mode | percentage of time using activated loop mode vs. deactivated loop mode | treatment period, an average of 1 year |
| SD and CV of CGM values | change of SD and CV of CGM values on 24hours and nighttime | through study completion, an average of 1 year |
| adverse event | number of adverse events | through study completion, an average of 1 year |
| Health Survey | change of the patient health, evaluated by questionnaire Short Form 12 Health Survey filled in at the beginning and at the end of the study | at the beginning and at the end of the study (1 year between each value) |
| Fear of hypoglycemia | change of the patient fear of hypoglycemia, evaluated by questionnaire Hypoglycemia fear survey filled in at the beginning and at the end of the study | at the beginning and at the end of the study (1 year between each value) |
| Patient stress status | change of the patient stress status, evaluated by questionnaire Diabetes distress scale, filled in at the beginning and at the end of the study | at the beginning and at the end of the study (1 year between each value) |
| Acceptability of the device | change of the patient's satisfaction of previous vs. DBLG1 System devices, evaluated by questionnaire patient stress status, filled in at the beginning and at the end of the study | at the beginning and at the end of the study (1 year between each value) |
| incidence of the system on the necessary healthcare professional charge | questionnaire at each visit (duration and type of visit, number and type of healthcare professional required for the visit) | through study completion, an average of 1 year |
| University Hospital, Toulouse |
| Principal Investigator |
| Sandrine Lablanche | University Hospital, Grenoble | Principal Investigator |
| Alfred Penfornis | CH Sud Francilien | Principal Investigator |
| Yves Reznik | University Hospital, Caen | Principal Investigator |
| Hôpital de la cavale blanche | Not yet recruiting | Brest | 29200 | France |
|
| CHU Caen | Recruiting | Caen | 14000 | France |
|
| Centre Hospitalier Sud Francilien | Not yet recruiting | Corbeil-Essonnes | 91100 | France |
|
| CHU Bocage Central | Recruiting | Dijon | 21079 | France |
|
| Hôpital Simone Veil | Not yet recruiting | Eaubonne | 95600 | France |
|
| CHU Grenoble | Recruiting | Grenoble | 38000 | France |
|
| Groupe Hospitalier La Rochelle - Ré - Aunis | Recruiting | La Rochelle | 17019 | France |
|
| CHU Lille | Not yet recruiting | Lille | 59037 | France |
|
| Diab-e-Care | Not yet recruiting | Lyon | 69008 | France |
|
| Hôpital Européen | Not yet recruiting | Marseille | 13003 | France |
|
| Hôpital la conception, pole ENDO | Not yet recruiting | Marseille | 13385 | France |
|
| hôpital Nord Laennec | Recruiting | Nantes | 44093 | France |
|
| Lariboisière - Fernand Widal APHP | Not yet recruiting | Paris | 75010 | France |
|
| Hôpital Bichet Claude Bernard - APHP | Not yet recruiting | Paris | 75018 | France |
|
| Clinique Princess | Not yet recruiting | Pau | 64000 | France |
|
| CHU Reims | Recruiting | Reims | 51100 | France |
|
| Hôpital Pontchaillou | Recruiting | Rennes | 35000 | France |
|
| Hôpital civil de Strasbourg | Recruiting | Strasbourg | 67000 | France |
|
| Hôpital de Rangueil | Not yet recruiting | Toulouse | 31400 | France |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |