Status:
RECRUITING
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
Lead Sponsor:
Medtrum France
Collaborating Sponsors:
Axonal-Biostatem
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-75 years
Brief Summary
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 hom...
Eligibility Criteria
Inclusion Criteria:
-
Patients living with Type 1 diabetes:
- adults aged 18 to 75 years old (included)
- children/adolescents aged 7 or older
-
Total daily dose of insulin ≥ 10 units per day & weighing >22 Kg
-
Patient and their parent(s)/guardian(s) trained and able to count carb
-
Current or previous insulin pump user or patient treated with multiple insulin injections
-
Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR < 70%, or TBR >4%
-
Any type of rapid insulin with a total daily insulin in the range of 10-60 IU (unauthorized use of insulin supplements by pen injector): Humalog™, Lyumjev (insulin lispro injection), Novorapid (insulin aspart) or FIASP® (" faster insulin aspart ")
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Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
-
Subject and their parent(s)/guardian(s) affiliated to the French social security system
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Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol
Exclusion Criteria:
- Patient unable to tolerate tape adhesive, catheter or had any unresolved adverse skin condition and intolerance to steel
- Patient not willing to perform finger stick blood glucose measurements required by the system and/or routine diabetes management
- Patient with behaviour/lifestyle not compatible with optimal management of insulin therapy or deemed to be at significant risk of severe events (e.g. severe hypoglycaemia, diabetic ketoacidosis)
- Unstable diabetic retinopathy
- Pregnant women or planning to become pregnant during the study or breast-feeding
- Patient abusing alcohol
- Patient using DPP-4 inhibitor, GLP-1 agonists, metformin, or SGLT2 inhibitors during the last 3 months prior screening
- Patient already participating in another interventional study
- Patient currently using a hybrid closed loop system or patient who has stopped usage of Hybrid Closed loop system for less than 3 months
- Patient under the protection of justice or under guardianship or curatorship, or hospitalised under duress or admitted to a health or social care establishment for purposes other than those of this investigation.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06363916
Start Date
April 15 2024
End Date
December 1 2025
Last Update
June 18 2024
Active Locations (17)
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1
CHU Angers
Angers, France
2
CHU Besançon
Besançon, France
3
CHU Bordeaux
Bordeaux, France
4
CHU Caen
Caen, France