Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363916
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-05
Brief Title:
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
Sponsor:
Medtrum France
Organization:
Medtrum France
Study Overview
Official Title:
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children Adolescents and Adults With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEECLOOP
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 mgdL 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 mgmL 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
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 mgdL 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 mgmL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None