Actively Recruiting
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
Led by Medtrum France · Updated on 2024-06-18
160
Participants Needed
17
Research Sites
85 weeks
Total Duration
On this page
Sponsors
M
Medtrum France
Lead Sponsor
A
Axonal-Biostatem
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study. The main question it aims to answer is : • Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ? Participants will be : * Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system * Randomized to the Open Loop or Closed Loop group * Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
CONDITIONS
Official Title
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Type 1 diabetes aged 7 to 75 years
- Total daily insulin dose of at least 10 units and weight over 22 kg
- Patient and parent(s)/guardian(s) trained and able to count carbohydrates
- Current or previous insulin pump user or treated with multiple insulin injections
- HbA1c between 7% and 12%, or Time In Range less than 70%, or Time Below Range over 4%
- Using rapid insulin types such as Humalog, Lyumjev, Novorapid, or FIASP with total daily insulin between 10-60 IU
- Patient and parent(s)/guardian(s) able to understand study information and give informed consent
- Affiliated with the French social security system
- Cognitive ability to operate all study devices and follow the protocol
You will not qualify if you...
- Unable to tolerate tape adhesive, catheter, or have unresolved skin conditions or steel intolerance
- Unwilling to perform finger stick blood glucose measurements
- Behavior or lifestyle incompatible with optimal insulin therapy or at high risk of severe events
- Unstable diabetic retinopathy
- Pregnant, planning pregnancy during the study, or breastfeeding
- Alcohol abuse
- Use of DPP-4 inhibitors, GLP-1 agonists, metformin, or SGLT2 inhibitors in the last 3 months
- Currently in another interventional study
- Currently using or stopped using a hybrid closed loop system less than 3 months ago
- Under legal protection, guardianship, or hospitalized against their will for non-study reasons
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Trial Site Locations
Total: 17 locations
1
CHU Angers
Angers, France
Not Yet Recruiting
2
CHU Besançon
Besançon, France
Not Yet Recruiting
3
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
4
CHU Caen
Caen, France
Not Yet Recruiting
5
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
Actively Recruiting
6
Centre Hospitalier de Gonesse
Gonesse, France
Actively Recruiting
7
Centre Hospitalier Saint-Louis
La Rochelle, France
Not Yet Recruiting
8
Hôpital Hôtel-Dieu
Le Creusot, France
Actively Recruiting
9
Hospices Civils de Lyon
Lyon, France
Not Yet Recruiting
10
Hôpital Européen
Marseille, France
Not Yet Recruiting
11
Hôpital La Timone
Marseille, France
Not Yet Recruiting
12
CHU Montpellier
Montpellier, France
Not Yet Recruiting
13
CHU Nantes
Nantes, France
Not Yet Recruiting
14
Hôpital Lariboisière
Paris, France
Not Yet Recruiting
15
Hôpital Necker
Paris, France
Not Yet Recruiting
16
Hôpital Robert Debré
Paris, France
Not Yet Recruiting
17
Hôpital Rangueil
Toulouse, France
Not Yet Recruiting
Research Team
M
Mélanie MARMOUNIER
CONTACT
D
Doris BARNIER-RIPET
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
2
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