Clinical trial NCT06471699: The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes
Official title: A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Research Council
name: Abbott Medical Devices
First posted: 2024-06-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Adults 18 years or older
3. Written Informed Consent
4. HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard) and less than 100 mmol/mol
5. Type 2 diabetes diagnosis \<4 weeks
6. Body mass index \> 25 kg/m2

Exclusion Criteria:

1. Pregnancy or planned pregnancy for the study duration
2. Type 1 diabetes
3. Judged to be in need of insulin
4. Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
5. History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
6. Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
7. Participation in another study.
8. Other investigator-determined criteria unsuitable for patient participation.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Time in range (TIR)
timeFrame: 6 months, 52 and 70 weeks
measure: Glucose variability
timeFrame: 6 months, 52 and 70 weeks
measure: Treatment satisfaction
timeFrame: 6 months, 52 and 70 weeks
measure: Well-being
timeFrame: 6 months, 52 and 70 weeks
measure: Weight
timeFrame: 6 months, 52 and 70 weeks
Other outcomes:
measure: Physical activity
timeFrame: 26,52 och 70 weeks
measure: Waist circumference
timeFrame: 26,52 och 70 weeks
measure: Fasting glucose
timeFrame: 26,52 och 70 weeks
measure: Blood pressure
timeFrame: 26,52 och 70 weeks
measure: Triglycerides
timeFrame: 26,52 och 70 weeks
measure: Reduction of HbA1c
timeFrame: 26,52 och 70 weeks
measure: Reduction of HbA1c
timeFrame: 26,52 och 70 weeks
measure: Time in high glucose levels
timeFrame: 26,52 och 70 weeks
Locations:
Study officials:
References: