Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471699
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-11
Brief Title:
The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
A Randomized Trial of the Effect of Continuous Glucose Monitoring CGM in Individuals With Newly Diagnosed Type 2 Diabetes
Status:
NOT_YET_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:
CHANGE-diab
Brief Summary:
The aim of the current study is to evaluate effectiveness sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks An extension period will exist between 26 and 70 weeks Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c CGM-metrics glucose-lowering medications physical activity treatment satisfaction and well-being
Detailed Description:
A keystone in preventing complications in persons with type 2 diabetes is good glycaemic control as soon as possible after onset of diabetes The basic treatment is optimizing lifestyle factors with increased physical activity weight control and a healthy diet In addition to glucose control it is important that blood pressure and blood lipids are well regulated Self-monitoring of blood glucose SMBG by repeated capillary glucose measurements has been a standard for regulating plasma glucose levels and to give information about the influence of lifestyle In recent years continuous glucose monitoring CGM has become an option for guiding the patient by immediate feedback on the influence of lifestyle such as physical activity and diet
Previous studies indicate that CGM helps and encourages people with type 2 diabetes to improve their lifestyle and that it is highly appreciated However it is relatively expensive and the effect of CGM on glycaemic control may fade over time
No previous study has examined the effect of CGM on lifestyle in individuals with newly diagnosed type 2 diabetes Individuals with newly diagnosed diabetes are more prone to change their lifestyle while quick improvement of glucose measurements also is of uttermost importance
The aim of the current study is to evaluate effectiveness sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks The primary endpoint is effect on HbA1c over 26 weeks Other essential endpoints over 26 weeks of treatment include effects on time in range glucose variability treatment satisfaction well-being and weight over 26 weeks of treatment Need of adding glucose lowering medications will also be compared between the treatment groups An extension period will exist between 26 and 70 weeks Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c CGM-metrics glucose-lowering medications physical activity treatment satisfaction and well-being
In total 238 patients will be included in this study carried out at 30 health care centres in Sweden
Previous studies indicate that CGM helps and encourages people with type 2 diabetes to improve their lifestyle and that it is highly appreciated However it is relatively expensive and the effect of CGM on glycaemic control may fade over time
No previous study has examined the effect of CGM on lifestyle in individuals with newly diagnosed type 2 diabetes Individuals with newly diagnosed diabetes are more prone to change their lifestyle while quick improvement of glucose measurements also is of uttermost importance
The aim of the current study is to evaluate effectiveness sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks The primary endpoint is effect on HbA1c over 26 weeks Other essential endpoints over 26 weeks of treatment include effects on time in range glucose variability treatment satisfaction well-being and weight over 26 weeks of treatment Need of adding glucose lowering medications will also be compared between the treatment groups An extension period will exist between 26 and 70 weeks Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c CGM-metrics glucose-lowering medications physical activity treatment satisfaction and well-being
In total 238 patients will be included in this study carried out at 30 health care centres in Sweden
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