Short summary

This pragmatic RCT evaluates the effect of continuous glucose monitoring (CGM) in adults with type 2 diabetes treated with insulin in general practice. Patients are randomized to immediate use of CGM or waitlist for 6 months. The primary outcome is between group difference in change in HbA1c over 6 months. Secondary outcomes include patient-reported measures, healthcare utilization, and qualitative interviews with patients and general practitioners.

Rationale

Studies have shown that adults with type 2 diabetes, particularly those treated with insulin, may benefit from continuous glucose monitoring (CGM). However, evidence on its use in general practice is still limited. This study aims to evaluate whether CGM can improve glycaemic outcomes and patient experience in a general practice setting in Denmark.

Description of the cohort

Adult patients with type 2 diabetes treated with insulin are recruited from general practices across three Danish regions. Potential participants are identified through medical records and invited by their general practitioner to learn more about the study. Eligible patients are randomized to either immediate or delayed (6 months) use of continuous glucose monitoring (CGM). Inclusion criteria are: type 2 diabetes, ongoing or planned insulin treatment, HbA1c > 53 mmol/mol, and age ≥ 18 years. Exclusion criteria include: pregnancy, no compatible smartphone, exemption from receiving Digital Post, inability to complete questionnaires in Danish (even with assistance), residence in nursing homes or supported housing, not self-managing insulin treatment, or current or previous use of CGM within the past 12 months. Both groups may use CGM for up to 12 months. For the first 6 months, CGM use is continuous, and if the HbA1c target is achieved, intermittent use follows, with CGM applied for 2 weeks prior to consultations.

Data and biological material

Data collected from patient records include: HbA1c levels, HbA1c targets, and the number and type of diabetes-related consultations with the general practitioner. Patient-reported data include questionnaires such as: PAID-5, PCD-5, EQ-5D-5L, and eHLQ (10 items). Qualitative data consist of interviews with general practitioners, practice nurses, and patients.

Collaborating researchers and departments

Steno Diabetes Centre Odense, University of Southern Denmark

• Arne Gårn
• Julie Dyrgaard
• Steno Diabetes Centre Sjælland
• Janne Kunchel Lorenzen

Steno Diabetes Centre Aarhus, Aarhus University Hospital

• Tina Quist