The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes
NCT Number: NCT06471699
Acronym: CHANGE-diab
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Type 2
Interventions: DEVICE: Continous Glucose Monitoring|OTHER: Self monitoring blood glucose
Sponsor: Vastra Gotaland Region
Collaborators: The Swedish Research Council|Abbott Medical Devices
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-11-01
Completion Date: 2030-12-31

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.

Primary Outcome Measures: HbA1c, Differences in changes in HbA1c between the CGM and SMBG group., 6 months
Secondary Outcome Measures: Time in range (TIR), Differences in changes Time in range (TIR) over 26 weeks of treatment measured by CGM between the CGM and SMBG group., 6 months, 52 and 70 weeks|Glucose variability, Differences in changes in Glucose variability over 26 weeks of treatment measured by CGM between the CGM and SMBG group., 6 months, 52 and 70 weeks|Treatment satisfaction, Differences in changes in treatment satisfaction over 26 weeks of treatment measured by validated questionnaires between the CGM and SMBG group. Treatment satisfaction measured with the questionnaires DTSQs (Diabetes Treatment Satisfaction Questionnaire, 0-48 points with best treatment 48p) and DTSQc follow-up (-24 to 24 points with best treatment 24P), 6 months, 52 and 70 weeks|Well-being, Differences in changes in well-being over 26 weeks of treatment measured by validated questionnaires between the CGM and SMBG group. Wellbeing will be measured with the questionnaires WHO5 (World Health Organisation, 0-25points with the best wellbeing 25P)., 6 months, 52 and 70 weeks|Weight, Differences in changes in weight over 26 weeks of treatment between the CGM and SMBG group., 6 months, 52 and 70 weeks
Other Outcome Measures: Physical activity, Exploratory objectives - differences in changes in physical activity measured with a questionnaire with self-reported data, IPAC (International Physical Activity Questionnaire, Physical activity estimated through transforming the answers about physical activity into METs with the highest METs as the most physicallay active) between the CGM and SMBG group., 26,52 och 70 weeks|Waist circumference, Exploratory objectives - differences in changes in waist circumference between the CGM and SMBG group., 26,52 och 70 weeks|Fasting glucose, Exploratory objectives - differences in changes in fasting glucose between the CGM and SMBG group., 26,52 och 70 weeks|Blood pressure, Exploratory objectives - differences in changes in blood pressure, both systolic and diastolic, between the CGM and SMBG group., 26,52 och 70 weeks|Triglycerides, Exploratory objectives - differences in changes in triglycerides between the CGM and SMBG group., 26,52 och 70 weeks|Reduction of HbA1c, Differences in changes of HbA1c by 5 mmol/mol (0.5% in DCCT) or more between the CGM and the SMBG group., 26,52 och 70 weeks|Reduction of HbA1c, Differences in changes of HbA1c by 10 mmol/mol (0.5% in DCCT) or more between the CGM and the SMBG group., 26,52 och 70 weeks|Time in high glucose levels, Differences in time of high glucose levels as measured by CGM (above 10.0 mmol/l and above 13.9 mmol/l) between the CGM and the SMBG group, 26,52 och 70 weeks