Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

Type 1 Diabetes Clinical Trial

— SEECLOOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363916
• Other study ID #: 2023-A00335-40
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Medtrum France
• Contact: Mélanie MARMOUNIER
• Phone: 0620591224
• Email: melanie.marmounier[@]medtrum.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Insulin Management System in Manual mode of operation
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
• Insulin Management System in Automatic mode of operation
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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHU Caen	Caen
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Centre Hospitalier de Gonesse	Gonesse
France	Centre Hospitalier Saint-Louis	La Rochelle
France	Hôpital Hôtel-Dieu	Le Creusot
France	Hospices Civils de Lyon	Lyon
France	Hôpital Européen	Marseille
France	Hôpital La Timone	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nantes	Nantes
France	Hôpital Lariboisière	Paris
France	Hôpital Necker	Paris
France	Hôpital Robert Debré	Paris
France	Hôpital Rangueil	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Medtrum France	Axonal-Biostatem

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR	Evolution of the time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations between visits V2-V6 and V5-V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements	Evolution of glucose sensor measurements (Mean value, Standard Deviation) between visits V2-V6 and V5-V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR	Evolution of the time spent >180 mg/dL and >250 mg/dL, from V2 to V6, and V5 to V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR	Evolution of the time spent <54 mg/dL and <70 mg/dL, from V2 to V6, and V5 to V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI	Evolution of glucose management indicator values from V2 to V6, from V5 to V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin	Modification of total daily dose of insulin, of basal dose of insulin and bolus dose of insulin from V2 to V6, from V5 to V6	V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months), V6 (7 months)
Other	Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores	Evolution of Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score between visits V5 and V6	V5 (6 months), V6 (7 months)
Primary	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	Evolution of TIR	Evolution of the time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations between visits V1-V2, V2-V4, V2-V5, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Evolution of coefficient of glycemic variation	Evolution of coefficient of glycemic variation (CV) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Superiority in Glycated Haemoglobin (HbA1c) improvement	Comparison between the 2 groups of the HbA1c change between visits V2 and V5	V2 (Randomisation), V5 (6 months)
Secondary	Evolution of Time spent Above Range (TAR)	Evolution of the time spent >180 mg/dL and >250 mg/dL, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Evolution of Time spent Below Range (TBR)	Evolution of the time spent <54 mg/dL and <70 mg/dL, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Body Mass Index change	Body Mass Index change (Mean value, Standard Deviation) between visits V1-V2, and V2-V5, in each group	V1 (Inclusion), V2 (Randomisation), V5 (6 months)
Secondary	Glucose sensor measurement change	Evolution of glucose sensor measurements (Mean value, Standard Deviation) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Percentage of patients with TIR > 70%	Percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%	Percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) and <4% of their time below range (54 to 70 mg/dL) and percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) and <1% of their time below range (54 to 70 mg/dL) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Evolution of glucose management indicator (GMI)	Evolution of glucose management indicator values between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Evolution of dosage of insulin	Modification of total daily dose of insulin, of basal dose of insulin and bolus dose of insulin between Visit V1-V2, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop)	Time of sensor usage in percentage and time spent in Auto Mode during study	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Secondary	Evolution of Self-administered Questionnaires scores	Evolution of Self-administered Questionnaire Hypoglycaemia Fear Survey (HFS) score between visits V1 and V5	V1 (Inclusion), V5 (6 months)
Secondary	Evolution of Diabetes Treatment Satisfaction score	Evolution of Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score between visits V1 and V5	V1 (Inclusion), V5 (6 months)
Secondary	Safety Events	Occurrence of Safety Events as defined by ISO 14155, including severe hypoglycaemia and ketoacidosis, local tolerance events related to devices (pump and sensor), incidents occuring with Medtrum devices	V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)