Evaluating the Medtrum Hybrid Closed Loop System for managing Type 1 Diabetes

Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes

This study is testing if the Medtrum Hybrid Closed Loop System can help people with Type 1 diabetes keep their blood sugar levels in a healthier range while using it at home.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 7 Years to 75 Years
• Sex: All
• Sponsor: Medtrum France (Industry-sponsored)
• Locations: 17 sites (Angers and 16 other locations)
• Trial ID: NCT06363916 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Medtrum Hybrid Closed Loop (HCL) System in individuals aged 7 to 75 years with Type 1 diabetes in a home setting. Participants will be trained to use the Medtrum A8 TouchCare® Insulin Management system and will be randomized into either an Open Loop or Closed Loop group. The primary goal is to determine if the HCL system increases the time spent in the target glucose range of 70-180 mg/dL compared to the Open Loop system. Participants will also complete self-administered questionnaires to assess their experiences and satisfaction with diabetes management.

Who should consider this trial

Good fit: Ideal candidates include children and adults aged 7 to 75 years with Type 1 diabetes who are currently not achieving optimal glycemic control.

Not a fit: Patients who are not living with Type 1 diabetes or those with HbA1c levels below 7% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glucose control and quality of life for patients with Type 1 diabetes.

How similar studies have performed: Previous studies have shown promising results with hybrid closed loop systems in diabetes management, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients living with Type 1 diabetes:

   * adults aged 18 to 75 years old (included)
   * children/adolescents aged 7 or older
2. Total daily dose of insulin ≥ 10 units per day \& weighing \>22 Kg
3. Patient and their parent(s)/guardian(s) trained and able to count carb
4. Current or previous insulin pump user or patient treated with multiple insulin injections
5. 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%
6. 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 ")
7. Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
8. Subject and their parent(s)/guardian(s) affiliated to the French social security system
9. 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:

1. Patient unable to tolerate tape adhesive, catheter or had any unresolved adverse skin condition and intolerance to steel
2. Patient not willing to perform finger stick blood glucose measurements required by the system and/or routine diabetes management
3. 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)
4. Unstable diabetic retinopathy
5. Pregnant women or planning to become pregnant during the study or breast-feeding
6. Patient abusing alcohol
7. Patient using DPP-4 inhibitor, GLP-1 agonists, metformin, or SGLT2 inhibitors during the last 3 months prior screening
8. Patient already participating in another interventional study
9. Patient currently using a hybrid closed loop system or patient who has stopped usage of Hybrid Closed loop system for less than 3 months
10. 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.

Where this trial is running

Angers and 16 other locations

• CHU Angers — Angers, France (Not_yet_recruiting)
• CHU Besançon — Besançon, France (Not_yet_recruiting)
• CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
• CHU Caen — Caen, France (Not_yet_recruiting)
• Centre Hospitalier Sud-Francilien — Corbeil-Essonnes, France (Recruiting)
• Centre Hospitalier de Gonesse — Gonesse, France (Recruiting)
• Centre Hospitalier Saint-Louis — La Rochelle, France (Not_yet_recruiting)
• Hôpital Hôtel-Dieu — Le Creusot, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
• Hôpital Européen — Marseille, France (Not_yet_recruiting)
• Hôpital La Timone — Marseille, France (Not_yet_recruiting)
• CHU Montpellier — Montpellier, France (Not_yet_recruiting)
• CHU Nantes — Nantes, France (Not_yet_recruiting)
• Hôpital Lariboisière — Paris, France (Not_yet_recruiting)
• Hôpital Necker — Paris, France (Not_yet_recruiting)
• Hôpital Robert Debré — Paris, France (Not_yet_recruiting)
• Hôpital Rangueil — Toulouse, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Freddy PENFORNIS — Centre Hospitalier Sud-Francilien, Corbeil
• Study coordinator: Mélanie MARMOUNIER

Conditions Type 1 Diabetes