Clinical trial NCT06363916: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
Official title: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Medtrum France
Sponsor class: INDUSTRY
Collaborators: name: Axonal-Biostatem
First posted: 2024-04-12
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups
timeFrame: V5 (6 months)
Secondary outcomes:
measure: Evolution of TIR
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Evolution of coefficient of glycemic variation
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Superiority in Glycated Haemoglobin (HbA1c) improvement
timeFrame: V2 (Randomisation), V5 (6 months)
measure: Evolution of Time spent Above Range (TAR)
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Evolution of Time spent Below Range (TBR)
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Body Mass Index change
timeFrame: V1 (Inclusion), V2 (Randomisation), V5 (6 months)
measure: Glucose sensor measurement change
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Percentage of patients with TIR > 70%
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Evolution of glucose management indicator (GMI)
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Evolution of dosage of insulin
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop)
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
measure: Evolution of Self-administered Questionnaires scores
timeFrame: V1 (Inclusion), V5 (6 months)
measure: Evolution of Diabetes Treatment Satisfaction score
timeFrame: V1 (Inclusion), V5 (6 months)
measure: Safety Events
timeFrame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Other outcomes:
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin
timeFrame: V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores
timeFrame: V5 (6 months), V6 (7 months)
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: CHU Caen
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse
city: La Rochelle
country: France
facility: Centre Hospitalier Saint-Louis
city: Le Creusot
country: France
facility: Hôpital Hôtel-Dieu
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital Européen
city: Marseille
country: France
facility: Hôpital La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Robert Debré
city: Toulouse
country: France
facility: Hôpital Rangueil
Study officials:
affiliation: Centre Hospitalier Sud-Francilien, Corbeil
name: Freddy PENFORNIS
role: PRINCIPAL_INVESTIGATOR
References: