Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
NCT ID: NCT06363916
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2024-04-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
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.
7 Years
75 Years
ALL
No
Sponsors
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Axonal-Biostatem
INDUSTRY
Medtrum France
INDUSTRY
Responsible Party
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Principal Investigators
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Freddy PENFORNIS
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Sud-Francilien, Corbeil
Locations
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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, , France
Countries
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Central Contacts
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Facility Contacts
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Regis COUTANT
Role: primary
Sophie BOROT
Role: primary
Bogdan CATARGI
Role: primary
Michael JOUBERT
Role: primary
Freddy PENFORNIS
Role: primary
Jennifer ALLAIN
Role: primary
Didier GOUET
Role: primary
Sylvaine CLAVEL
Role: primary
Charles THIVOLET
Role: primary
Denis RACCAH
Role: primary
Rachel REYNAUD
Role: primary
Fabienne DALLA VALE
Role: primary
Lucy CHAILLOUS
Role: primary
Jean-Pierre RIVELINE
Role: primary
Jacques BELTRAND
Role: primary
Elise BISMUTH
Role: primary
Vincent MELKI
Role: primary
Other Identifiers
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2023-A00335-40
Identifier Type: -
Identifier Source: org_study_id
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