MATERIALS AND METHODS
T1D, hypoglycaemia, T2D, diabetes
SECONDARY, HYPOGLYCAEMIA, DIABETES
The ANSHIN study was a prospective, interventional study with a single‐arm primary phase (phase one) and a randomized secondary phase (phase two). Participants underwent two sequential 10‐day run‐in periods using blinded CGM (G6 Pro, Dexcom, Inc.) to collect baseline data. During these run‐in periods, participants used SMBG data (Ascensia Contour NEXT 1 m) for diabetes treatment decisions. After run‐in, participants entered phase one of the study, a 16‐week intervention period during which participants were instructed to use CGM non‐adjunctively unless the CGM values did not align with symptoms or expectations. Participants were provided with a locked Android smartphone equipped with the Dexcom G6 commercial application, the Share/Follow application to share CGM data with others, and the Dexcom Clarity application to view and interact with CGM data. Initial high and low alerts were set to 13.9 mmoL/L and 3.9 mmoL/L, respectively; alerts for signal loss and upcoming hypoglycaemia were enabled. Participants could use the applications and features at their discretion. Study staff did not provide education about the use of CGM data nor were participants instructed to change their insulin treatment regimens. The study staff also did not provide guidance to participants or their healthcare providers to titrate toward specific glycaemic targets. Participants who completed the first phase were invited to continue to phase two.In phase two, participants were randomly assigned (1:1) to wear two systems with either an updatedFlowchart of clinic visits and study completion.Adults aged 18 and older with T1D or T2D were enrolled at five sites in the United States. Participants were eligible if they had been diagnosed at least six months prior to enrollment, had used IIT to manage their diabetes for the last ≥3 months, had an HbA1c value of ≥7.5% within 30 days prior to enrollment or at screening, were currently performing ≥2 SMBG measurements per day, were willing to use the study‐provided SMBG meter and were willing to participate in both phases of the trial. Exclusion criteria included use of a CGM in the six months prior to enrollment (with the exception of professional blinded CGM), BMI >45 kg/mThe primary outcome was the change in HbA1c from the baseline SMBG monitoring period to the end of phase one. Secondary outcomes for both phases were CGM metrics (e.g., time in range [TIR], time below range [TBR] and time above range [TAR]). CGM metrics calculated at baseline included all blinded CGM data during the 20‐day run‐in period and CGM metrics calculated at phase one follow‐up included all unblinded CGM data in the 20 days prior to 16‐week follow‐up visit. CGM metrics were computed if there were at least 10 days of CGM data in the respective period. In addition to calculating overall results, the impact of CGM intervention was examined for the following subgroups: T1D, T2D and older adults (≥65 years).The changes in study endpoints from baseline to the end of phase one were compared using two‐sided paired The study was 90% powered to detect a difference in mean HbA1c between baseline and the end of phase one, assuming a mean difference of 0.4% from baseline, a common standard deviation of 0.7%, a correlation of 0.4, a significance level of 0.05 and using a two‐sided paired 