The Effect of Continuous Glucose Monitoring in Individuals With Newly Diagnosed Type 2 Diabetes

NCT ID: NCT06471699

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2030-12-31

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

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Continous Glucose Monitoring

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

Group Type: EXPERIMENTAL

Continous Glucose Monitoring

Intervention Type: DEVICE

The aim is to examine if the use of CGM will give the participants a significant support to implement lifestyle improvements in individuals with new on-set type 2 diabetes

Self Monitoring Blood Glucose

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

Group Type: ACTIVE_COMPARATOR

Self monitoring blood glucose

Intervention Type: OTHER

Capillary testing as in standard procedure

Interventions

Continous Glucose Monitoring

The aim is to examine if the use of CGM will give the participants a significant support to implement lifestyle improvements in individuals with new on-set type 2 diabetes

Intervention Type: DEVICE

Self monitoring blood glucose

Capillary testing as in standard procedure

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Margareta Hellgren, PI

Role: CONTACT

margareta.leonardsson-hellgren@vgregion.se

+46708381612

Marcus Lind, Co-PI

Role: CONTACT

marcus.lind@gu.se

+46700824239

Other Identifiers

282418

Identifier Type: -

Identifier Source: org_study_id