There are beneficial effects of both the use of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM). The aim of this study is to compare the effects on glycemic control of isCGM, and/or training in carbohydrate counting with ABC vs. standard treatment in persons naïve to both interventions.
A randomized controlled trial carried out at five sites in The Capital Region, Denmark, with inclusion criteria; ≥18 years, T1D ≥1 year, HbA1c >53 mmol/mol, MDI therapy, whereas use of advanced carbohydrate counting / CGM wear are exclusion criteria. Inclusion was initiated in August 2018 and is ongoing. Eligible persons are randomized into 4 groups; A (control), B (ABC), C (isCGM) or D (ABC + isCGM). The devices used are smart phone MySugr application and FreeStyle Libre flash (Abbott Diabetes Care). Participants attend group courses of 4.5 hours duration according to group allocation with different educational content; general diabetes, ABC, MySugr app, FreeStyle Libre Flash and advanced FreeStyle Libre Flash. Participants are followed for 26 weeks with 6 clinical visits. At baseline and at study end, participants wear blinded CGM (FreeStyle Libre Professional, Abbott Diabetes Care), have blood samples performed (HbA1c, safety) and fill in questionnaires (PAID, DTSQ, DES-SF and ADDQoL-19). At baseline, they also filled in NEO-FFI-3.
The primary outcome is the difference at study end vs. baseline between groups C (isCGM) and A (control) in time spent in normoglycemia (4-10 mmol/l). Secondary outcomes will also be analyzed.
Results are expected in 2020.