Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Diabetes Self-management With Continuous Glucose Monitoring
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
DIASELF
Brief Summary:
The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring CGM and the impact of this interaction on quality of life particularly the level of diabetes distress and glycaemic metrics
Participants will
Visit the clinic twice with a 14-day interval
Fill out a survey before the first and at the last visit
Use CGM as usual and use smart insulin pens and an activity tracker
Register food intake
Answer two-three questions twice a day in REDCap
Participants will
Visit the clinic twice with a 14-day interval
Fill out a survey before the first and at the last visit
Use CGM as usual and use smart insulin pens and an activity tracker
Register food intake
Answer two-three questions twice a day in REDCap
Detailed Description:
A two-centre observational study conducted in Denmark including adults with type 1 diabetes n500 on multiple daily injections already using FreeStyle Libre 2
Upon recruitment participants will complete a survey of 11 validated questionnaires including T1-DDS-28 For 14 days participants will continue regular CGM use smart insulin pens will record real-time insulin dosage and an activity sensor will monitor physical activity and sleep Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap At the end of the study participants will complete the T1-DDS-28 and Health Literacy Questionnaire
Our primary objectives is to investigate the association between diabetes distress assessed by Type 1 Diabetes Distress Scale T1-DDS-28 and
1 frequency of reading CGM data
2 frequency of low glucose alarms
3 frequency of high glucose alarms
4 frequency of daily between-meal insulin corrections
5 frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin
6 frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates and
7 sociodemographic and psychosocial characteristics of CGM users
Our secondary objective is to investigate the association between glycaemic metrics and the variables described above Glycaemic metrics will be reported as CGM-metrics including time in range defined as the percentage of time the sensor glucose is 39-100 mmolL 70-180 mgdL per international consensus ATTD 2022
Upon recruitment participants will complete a survey of 11 validated questionnaires including T1-DDS-28 For 14 days participants will continue regular CGM use smart insulin pens will record real-time insulin dosage and an activity sensor will monitor physical activity and sleep Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap At the end of the study participants will complete the T1-DDS-28 and Health Literacy Questionnaire
Our primary objectives is to investigate the association between diabetes distress assessed by Type 1 Diabetes Distress Scale T1-DDS-28 and
1 frequency of reading CGM data
2 frequency of low glucose alarms
3 frequency of high glucose alarms
4 frequency of daily between-meal insulin corrections
5 frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin
6 frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates and
7 sociodemographic and psychosocial characteristics of CGM users
Our secondary objective is to investigate the association between glycaemic metrics and the variables described above Glycaemic metrics will be reported as CGM-metrics including time in range defined as the percentage of time the sensor glucose is 39-100 mmolL 70-180 mgdL per international consensus ATTD 2022
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