Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

Sophiahemmet University

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Periodic CGM group with data analysis report- Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT05633628

Periodic Glucose Insights

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Periodic CGM- Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Periodic CGM group with data analysis report- Intervention group

Self-monitoring of blood glucose, SMBG and usual care - Control Group

No Intervention group

Description:

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.