NCT05633628

Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Sophiahemmet University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.

Detailed description

This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden. Periodic CGM group- Intervention group: The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning. Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Periodic CGM group with data analysis report- Intervention group	The patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-12-01
• Last updated: 2025-05-15

Locations

1 site across 1 country: Sweden