The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes (CHANGE-diab)

Vastra Gotaland Region

Status: Not yet enrolling

Conditions: Diabetes Type 2

Treatments: Other: Self monitoring blood glucose; Device: Continous Glucose Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06471699

282418

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Continous Glucose Monitoring

Experimental group

Description:

Participants will be randomized to intervention Continous Glucose Monitoring (CGM)

Treatment:

Device: Continous Glucose Monitoring

Self Monitoring Blood Glucose

Active Comparator group

Description:

Participants will be randomized to control Self Monitoring Blood Glucose (SMBG)

Treatment:

Other: Self monitoring blood glucose