Using continuous glucose monitoring to improve care for 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
This study tests if using a continuous glucose monitor can help adults with type 2 diabetes manage their blood sugar better than traditional blood sugar testing methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sophiahemmet University Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05633628 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effectiveness of periodic continuous glucose monitoring (CGM) compared to self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes. Over 16 weeks, participants will either use the FreeStyle Libre CGM system or continue with traditional SMBG methods. The study aims to enhance glucose control and patient-reported outcomes through a person-centered approach, involving discussions between patients and diabetes nurses about their glucose data. The trial is conducted across multiple primary care practices in Sweden.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with type 2 diabetes for more than 6 months and who have experience with self-monitoring blood glucose.
Not a fit: Patients currently using prandial insulin, those with severe visual impairments, or those with active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glucose control and better self-management for patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown positive outcomes with continuous glucose monitoring in diabetes management, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Sophiahemmet University — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Unn-Britt Johansson — Sophiahemmet University
- Study coordinator: Unn-Britt Johanssson, Professor
- Email: unn-britt.johansson@shh.se
- Phone: +4684062902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.