Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System (SEECLOOP)

Medtrum

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Insulin Management System in Manual mode of operation; Device: Insulin Management System in Automatic mode of operation

Study type: Observational

Funder types: Industry

Identifiers

NCT06363916

2023-A00335-40

Details and patient eligibility

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 7 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

Open Loop

Description:

Patients using the Insulin Management System device in a manual mode of operation. Patient must use the interface directly to deliver insulin. The algorithm will not be activated.

Treatment:

Device: Insulin Management System in Manual mode of operation

Closed Loop

Description:

Patients using the Insulin Management System device in the Closed Loop mode of operation. The algorithm will be activated. The algorithm is capable of delivery of insulin based on sensor derived glucose levels, glucose level trends and insulin pump delivery history. Patients in this group can continue to an exploratory phase for the Automatic Meal Management function.

Treatment:

Device: Insulin Management System in Automatic mode of operation