An observational study in Type1diabetes, sponsored by Diabeloop. Status unknown at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Diabeloop · Observational
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 348 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Diabeloop is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with type 1 diabetes equal or more than 18 years old, with Hb1Ac ≥ 8%
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
only group included in the study
Device: DBLG1 System
Use of DBLG1 System in real life condition
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
Time frame: through study completion, an average of 1 year
HbA1c HbA1c HbA1c
change in the HbA1c after 1 year of use of the device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
use of loop mode
percentage of time using activated loop mode vs. deactivated loop mode
Time frame: 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
Time frame: through study completion, an average of 1 year
adverse event
number of adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Jul 2025, 50 months after the start.
Of 49 industry-sponsored observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 50 months is above that.
Counting every sponsor, half of 288 studies reached it within 27 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Diabeloop