Overview
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.
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.
Eligibility
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
