Actively Recruiting
Observational Study of the Use of DBLG1 System in Real Life
Led by Diabeloop · Updated on 2024-05-07
348
Participants Needed
20
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Observational Study of the Use of DBLG1 System in Real Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with type 1 diabetes
- Patients who are at least 18 years old
- Patients with a total daily insulin dose less than 90 units
- Patients agreeing to be treated with 100 U/mL rapid-acting insulin analog
- Patients having a HbA1c of 8% or higher despite using an insulin pump for at least 6 months
- Patients performing glucose self-monitoring four or more times per day
- Patients accepting the technology
- Patients agreeing to use the system with activated loop mode at least 75% of the total time
- Patients must be affiliated to any kind of social security
You will not qualify if you...
- Patients receiving a total daily insulin dose lower than 8 units
- Patients with serious illness or treatments that may impair diabetes physiology or interfere with the device (e.g., iSGLT2, steroids, metformin)
- Patients with severe uncorrected hearing or vision problems preventing proper use of the DBLG1 System
- Patients unable to understand and follow all instructions regarding the device and the study
- Patients planning repeated MRI, CT scans, or high-frequency electrical heat treatments during the study year
- Patients unwilling or unable to maintain contact with healthcare professionals
- Patients who want to use insulin types other than 100 U/mL rapid-acting insulin analog with the system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Hôpital Avicenne APHP
Bobigny, France, 93000
Not Yet Recruiting
2
Hôpital de la cavale blanche
Brest, France, 29200
Not Yet Recruiting
3
CHU Caen
Caen, France, 14000
Actively Recruiting
4
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Not Yet Recruiting
5
CHU Bocage Central
Dijon, France, 21079
Actively Recruiting
6
Hôpital Simone Veil
Eaubonne, France, 95600
Not Yet Recruiting
7
CHU Grenoble
Grenoble, France, 38000
Actively Recruiting
8
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle, France, 17019
Actively Recruiting
9
CHU Lille
Lille, France, 59037
Not Yet Recruiting
10
Diab-e-Care
Lyon, France, 69008
Not Yet Recruiting
11
Hôpital Européen
Marseille, France, 13003
Not Yet Recruiting
12
Hôpital la conception, pole ENDO
Marseille, France, 13385
Not Yet Recruiting
13
hôpital Nord Laennec
Nantes, France, 44093
Actively Recruiting
14
Lariboisière - Fernand Widal APHP
Paris, France, 75010
Not Yet Recruiting
15
Hôpital Bichet Claude Bernard - APHP
Paris, France, 75018
Not Yet Recruiting
16
Clinique Princess
Pau, France, 64000
Not Yet Recruiting
17
CHU Reims
Reims, France, 51100
Actively Recruiting
18
Hôpital Pontchaillou
Rennes, France, 35000
Actively Recruiting
19
Hôpital civil de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
20
Hôpital de Rangueil
Toulouse, France, 31400
Not Yet Recruiting
Research Team
M
Marion Chassouant
CONTACT
E
Erik Huneker
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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