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L'essai clinique NCT06363916 (SEECLOOP) pour Diabète de type 1 est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System (SEECLOOP)
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L'étude clinique NCT06363916 (SEECLOOP) est un essai observationnel pour Diabète de type 1. Son statut actuel est : en recrutement. L'étude a débuté le 15 avril 2024 et vise à recruter 160 participants. Dirigé par Medtrum France, l'essai devrait être terminé d'ici le 1 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 juin 2024.
Résumé succinct
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.
Titre officiel
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
Conditions
Diabète de type 1Autres identifiants de l'essai
- SEECLOOP
- 2023-A00335-40
Numéro NCT
Date de début (réel)
2024-04-15
Dernière mise à jour publiée
2024-06-18
Date de fin (estimée)
2025-12
Inscription (estimée)
160
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
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 |
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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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) |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
7 Years
Sexes éligibles
Tous
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
- 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.
Medtrum FranceAxonal-BiostatemContact central de l'essai
Contact: Mélanie MARMOUNIER, 0620591224, [email protected]
Contact: Doris BARNIER-RIPET, 0776151479, [email protected]
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