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

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.

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.

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 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-management care 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.

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.

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.

Number of hyperglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic

Number of hypoglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic

Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic

Postprandial peak during 2 hours for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic

The 4Ps is a questionnaire including 12 items comprising patient´s preferences as well as experiences.

Inclusion Criteria: Adults aged 18-80 years Type 2 diabetes with a duration of > 6 months HbA1c 45-70 mmol/mol Have a smartphone Experience of self-monitoring of blood glucose prior to the study start Exclusion Criteria: Prandial insulin Pregnancy or planning pregnancy during the study Breastfeeding Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2 Active malignancy or under investigation for malignancy Severe visual impairment Severe skin allergy that inhibits the use of a continuous glucose monitoring device Glucocorticoids (systemic) Planned or currently using weight reduction medications, programs, or surgery Cognitively or psychologically unable to participate and read instructions Enrolled in other clinical trials Eating disorders