Non‐adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post‐approval observational study

Abstract

Prior to the Continuous Monitoring and Control of Hypoglycaemia (COACH) study described herein, no study had been powered to evaluate the impact of non-adjunctive RT-CGM use on the rate of debilitating moderate or severe hypoglycaemic events. Research Design and Methods: In this 12-month observational study, adults with insulin-requiring diabetes who were new to RT-CGM participated in a 6month control phase where insulin dosing decisions were based on self monitoring of blood glucose values, followed by a 6-month phase where decisions were based on RT-CGM data (i.e. non-adjunctive RT-CGM use); recommendations for RT-CGM use were made according to sites' usual care. The primary outcome was change in debilitating moderate (requiring second-party assistance) and severe (resulting in seizures or loss of consciousness) hypoglycaemic event frequency. Secondary outcomes included changes in HbA1c and diabetic ketoacidosis (DKA) frequency.Results: A total of 519 participants with mean (SD) age 50.3 (16.1) years and baseline HbA1c 8.0% (1.4%) completed the study, of whom 32.8% had impaired hypoglycaemia awareness and 33.5% had type 2 diabetes (T2D). The mean (SE) per-patient frequency of hypoglycaemic events decreased by 63% from 0.08 (0.016) during the SMBG phase to 0.03 (0.010) during the RT-CGM phase (p = 0.005).HbA1c decreased during the RT-CGM phase both for participants with type 1 diabetes (T1D) and T2D and there was a trend towards larger reductions among individuals with higher baseline HbA1c.Conclusions: Among adults with insulin-requiring diabetes, non-adjunctive use of RT-CGM data is safe, resulting in significantly fewer debilitating hypoglycaemic events than management using SMBG.

Assessing non‐adjunctive CGM safety at home and in new markets (ANSHIN)

“…Participants in the ANSHIN study had fewer episodes of SH while using the G6 compared to the baseline SMBG period. This observation aligns with the COACH study that reported non‐adjunctive Dexcom G5 use was associated with reductions in hypoglycaemic events for patients with insulin‐treated T1D or T2D 8 . Hypoglycaemia mitigation may be partly attributable to CGM alerts and alarms that warn users of impending low glucose.…”

“…The 2017 REPLACE‐BG study further demonstrated that using CGM data in place of SMBG testing as the basis for diabetes treatment decisions was safe for adults with T1D. 7 In addition, the COACH 8 study and the DIAMOND 5 and MOBILE 9 randomized clinical trials demonstrated that CGM use improved glycaemic control in people with diabetes better than SMBG, including greater reduced HbA1c, fewer SH events and improved CGM‐based metrics.…”

Variance of concern

“…In this issue of Diabetic Medicine, the impact of realtime continuous glucose monitoring with alerts and alarms (rtCGM) on severe hypoglycaemia is reported. 3 Previous studies have demonstrated the impact of rtCGM on hypoglycaemia exposure 4,5 and severe hypoglycaemia has been shown to be reduced in adults with type 1 diabetes at highest risk, 6 but this study replicated the beneficial impact on severe hypoglycaemia in rtCGM-naïve participants with insulin-treated type 2 diabetes and shows that this clinically important impact can be achieved with regular phone contact. As remote support for people with diabetes becomes embedded, and sensor access increases these findings will be increasingly important and impactful, both clinically and for cost-effectiveness analyses.…”

Continuous glucose monitoring

“…Additionally, CGM glucose trend arrows provide additional contextual information above and beyond the reliability of any single data point from finger stick blood glucose testing, enabling individuals to see past and recent glucose levels and observe recent trends 373839…”

“…A 12-month observational study in 519 adults with insulin-requiring diabetes (types 1 and 2) observed a 63% reduction in frequency of hypoglycaemia compared with finger stick blood glucose testing 38…”