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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Insulin Management System in Manual mode of operation; Device: Insulin Management System in Automatic mode of operation

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Mélanie MARMOUNIER; Phone Number: 0620591224; Email: melanie.marmounier@medtrum.fr
• Study Contact Backup: Name: Doris BARNIER-RIPET; Phone Number: 0776151479; Email: seecloop@axonal.com

Study Locations

• France
  • Angers, France
    • Not yet recruiting
    • CHU Angers
    • Principal Investigator: Regis COUTANT
    • Contact: Regis COUTANT
  • Besançon, France
    • Not yet recruiting
    • CHU Besançon
    • Principal Investigator: Sophie BOROT
    • Contact: Sophie BOROT
  • Bordeaux, France
    • Not yet recruiting
    • CHU Bordeaux
    • Contact: Bogdan CATARGI
    • Principal Investigator: Bogdan CATARGI
  • Caen, France
    • Not yet recruiting
    • CHU caen
    • Contact: Michael JOUBERT
    • Principal Investigator: Michael JOUBERT
  • Corbeil-Essonnes, France
    • Recruiting
    • Centre Hospitalier Sud-Francilien
    • Contact: Freddy PENFORNIS
    • Principal Investigator: Freddy PENFORNIS
    • Principal Investigator: Thanh-Lan DANG DUY
  • Gonesse, France
    • Recruiting
    • Centre Hospitalier de Gonesse
    • Contact: Jennifer ALLAIN
    • Principal Investigator: Jennifer ALLAIN
  • La Rochelle, France
    • Not yet recruiting
    • Centre Hospitalier Saint-Louis
    • Principal Investigator: Didier GOUET
    • Contact: Didier GOUET
  • Le Creusot, France
    • Recruiting
    • Hôpital Hôtel-Dieu
    • Principal Investigator: sylvaine clavel
    • Contact: sylvaine clavel
  • Lyon, France
    • Not yet recruiting
    • Hospices Civils de Lyon
    • Contact: Charles Thivolet
    • Principal Investigator: Charles Thivolet
  • Marseille, France
    • Not yet recruiting
    • Hôpital Européen
    • Contact: Denis RACCAH
    • Principal Investigator: Denis RACCAH
  • Marseille, France
    • Not yet recruiting
    • Hôpital la Timone
    • Contact: Rachel REYNAUD
    • Principal Investigator: Rachel Reynaud
  • Montpellier, France
    • Not yet recruiting
    • CHU Montpellier
    • Contact: Fabienne DALLA VALE
    • Principal Investigator: Fabienne DALLA VALE
  • Nantes, France
    • Not yet recruiting
    • CHU Nantes
    • Contact: Lucy CHAILLOUS
    • Principal Investigator: Lucy CHAILLOUS
  • Paris, France
    • Not yet recruiting
    • Hôpital Necker
    • Principal Investigator: Jacques BELTRAND
    • Contact: Jacques BELTRAND
  • Paris, France
    • Not yet recruiting
    • Hôpital Lariboisière
    • Contact: Jean-Pierre RIVELINE
    • Principal Investigator: Jean-Pierre RIVELINE
  • Paris, France
    • Not yet recruiting
    • Hôpital Robert Debré
    • Principal Investigator: Elise Bismuth
    • Contact: Elise Bismuth
  • Toulouse, France
    • Not yet recruiting
    • Hopital Rangueil
    • Contact: Vincent MELKI
    • Principal Investigator: Vincent MELKI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Medtrum France
• Collaborators: Axonal-Biostatem
• Investigators: Principal Investigator: Freddy PENFORNIS, Centre Hospitalier Sud-Francilien, Corbeil

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2023-A00335-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No