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.

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