Validity of Danish public criteria for providing flash glucose monitoring to participants with type 1 diabetes—An explorative cohort study

Abstract

Abstract Introduction Flash glucose monitor (FGM) use is increasing. A set of Danish criteria for regulating the use has been released. We assessed their validity. Methods Patients with type 1 diabetes attending our clinic were offered Freestyle Libre Sensor for 12 months and stratified into fulfilling the Danish regional criteria (RC+) or not (RC−). Primary endpoint was achieving individualized target HbA1c. Secondary endpoints were HbA1c reduction ≥5%, time in range (TIR), time below range (TBR), daily scans, change in median HbA1c, and noted experiences. Results Two hundred seventy‐eight participants were included. Forty‐four participants met target HbA1c after 1 year. No difference between RC+ and RC− was observed (p = .136). Higher age was associated with probability to meet target HbA1c (RR = 3.15, [95% CI: 1.15, 8.62]) as was frequent scans (RR = 1.88, [95% CI: 0.99, 3.57]). One hundred twenty‐three participants met an HbA1c reduction ≥5%, the majority represented in RC+ (p = .023). Higher baseline HbA1c was associated with a reduction of HbA1c ≥5% after 1 year (RR = 1.97, [95% CI: 1.40, 2.78]). There was no difference between RC+ and RC− in TIR, TBR, and daily scans. Positive experiences dominated from both participants and healthcare professionals. More positive experiences were noted from healthcare professionals in RC− (p = .003) but no difference in reported experiences among participants in RC+ and RC− (p = .880). Conclusion The Danish Regional Criteria seems not a valid tool for regulation of FGM. Participants of older age and participants with more frequent daily scans might benefit more from FGM.

Keywords

• Danish public regulatory criteria
• flash glucose monitor
• HbA1c target achievement
• predictors
• type 1 diabetes