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

NCT06471699 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-06-24

No results posted yet for this study

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

Interventions

DEVICE

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

OTHER

Self monitoring blood glucose

Capillary testing as in standard procedure

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Vastra Gotaland Region

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2027-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06471699 on ClinicalTrials.gov