Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT06453434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Self-management With Continuous Glucose Monitoring
Sponsor:
Nordsjaellands Hospital
Organization:
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 (n=500) 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 3.9-10.0 mmol/L (70-180 mg/dL), 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 3.9-10.0 mmol/L (70-180 mg/dL), per international consensus (ATTD, 2022)
Study Oversight
Has Oversight DMC:
False
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?: