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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
Sophiahemmet University
RECRUITING
Stockholm
Contact Information
Primary
Unn-Britt Johanssson, Professor
unn-britt.johansson@shh.se
+4684062902
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 400
Treatments
Experimental: Periodic CGM- 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 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Sophiahemmet, Swedish Diabetes Foundation, OneTwo Analytics AB
Leads: Sophiahemmet University