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

NCT06471699 | Not Yet Recruiting

• 1 other identifier: 282418
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Differences in changes in HbA1c between the CGM and SMBG group.

  6 months

Secondary Outcomes (5)

• Time in range (TIR)

  6 months, 52 and 70 weeks

• Glucose variability

  6 months, 52 and 70 weeks

• Treatment satisfaction

  6 months, 52 and 70 weeks

• Well-being

  6 months, 52 and 70 weeks

• Weight

  6 months, 52 and 70 weeks

Other Outcomes (8)

• Physical activity

  26,52 och 70 weeks

• Waist circumference

  26,52 och 70 weeks

• Fasting glucose

  26,52 och 70 weeks

Study Arms (2)

Continous Glucose Monitoring

EXPERIMENTAL

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

Device: Continous Glucose Monitoring

Self Monitoring Blood Glucose

ACTIVE COMPARATOR

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

Other: Self monitoring blood glucose

Interventions

Continous Glucose Monitoring 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

Continous Glucose Monitoring

Self monitoring blood glucose OTHER

Capillary testing as in standard procedure

Self Monitoring Blood Glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or planned pregnancy for the study duration
• Type 1 diabetes
• Judged to be in need of insulin
• History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
• Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
• Participation in another study.
• Other investigator-determined criteria unsuitable for patient participation.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• The Swedish Research Council: collaborator
• Abbott Medical Devices: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Central Study Contacts

Margareta Hellgren, PI

CONTACT

+46708381612; margareta.leonardsson-hellgren@vgregion.se

Marcus Lind, Co-PI

CONTACT

+46700824239; marcus.lind@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 24, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 24, 2024

Record last verified: 2024-06