Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

NCT06363916 | Recruiting DMC

• 1 other identifier: 2023-A00335-40
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 17

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 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

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups

  Comparison between the 2 groups of the proportion of time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations during last 12 weeks of the study

  V5 (6 months)

Secondary Outcomes (15)

• Evolution of TIR

  V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)

• Evolution of coefficient of glycemic variation

  V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)

• Superiority in Glycated Haemoglobin (HbA1c) improvement

  V2 (Randomisation), V5 (6 months)

• Evolution of Time spent Above Range (TAR)

  V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)

• Evolution of Time spent Below Range (TBR)

  V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)

Other Outcomes (7)

• Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR

  V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)

• Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements

  V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)

• Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR

  V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)

Study Arms (2)

Open Loop

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.

Device: Insulin Management System in Manual mode of operation

Closed Loop

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.

Device: Insulin Management System in Automatic mode of operation

Interventions

Insulin Management System in Manual mode of operation DEVICE

MEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm not activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020

Open Loop

Insulin Management System in Automatic mode of operation DEVICE

MEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020

Closed Loop

Eligibility Criteria

• Age: 7 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetes subjects with insulin therapy delivered by pump (aged over 7 years), current or previous insulin pump user or patient treated with multiple insulin injections.

You may qualify if:

• 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 ")
• 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
• Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtrum France: lead
• Axonal-Biostatem: collaborator

Study Sites (17)

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Freddy PENFORNIS

  Centre Hospitalier Sud-Francilien, Corbeil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie MARMOUNIER

CONTACT

0620591224; melanie.marmounier@medtrum.fr

Doris BARNIER-RIPET

CONTACT

0776151479; seecloop@axonal.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 12, 2024
• Study Start: April 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

FR (17)