Journal Article

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

Chao, Christy, Welsh, John B., Andrade, Sarah B., Bergford, Simon, Calhoun, Peter, Walker, Tomas C.

2023

Overview

Introduction Continuous glucose monitoring (CGM) can guide treatment for people with type 1 (T1D) and type 2 diabetes (T2D). The ANSHIN study assessed the impact of non‐adjunctive CGM use in adults with diabetes using intensive insulin therapy (IIT). Materials and Methods This single‐arm, prospective, interventional study enrolled adults with T1D or T2D who had not used CGM in the prior 6 months. Participants wore blinded CGMs (Dexcom G6) during a 20‐day run‐in phase, with treatment based on fingerstick glucose values, followed by a 16‐week intervention phase and then a randomized 12‐week extension phase with treatment based on CGM values. The primary outcome was change in HbA1c. Secondary outcomes were CGM metrics. Safety endpoints were the number of severe hypoglycaemic (SH) and diabetic ketoacidosis (DKA) events. Results Of the 77 adults enrolled, 63 completed the study. Those enrolled had mean (SD) baseline HbA1c of 9.8% (1.9%), 36% had T1D, and 44% were ≥65 years old. Mean HbA1c decreased by 1.3, 1.0 and 1.0 percentage points for participants with T1D, T2D or age ≥65, respectively (p < .001 for each). CGM‐based metrics including time in range also improved significantly. SH events decreased from the run‐in period (67.3 per 100 person‐years) to the intervention period (17.0 per 100 person‐years). Three DKA events unrelated to CGM use occurred during the total intervention period. Conclusions Non‐adjunctive use of the Dexcom G6 CGM system improved glycaemic control and was safe for adults using IIT. ANSHIN is a single‐arm, prospective, interventional study that assessed the impact of non‐adjunctive Dexcom G6 continuous glucose monitoring (CGM) in adults with diabetes using intensive insulin therapy. After initiating CGM use, severe hypoglycemic events decreased and mean HbA1c decreased by 1.3, 1.0, and 1.0 percentage points for participants with type 1 diabetes (T1D), type 2 diabetes (T2D), or age ≥65, respectively (p<.001 for each) after 16 weeks. Non‐adjunctive use of CGM improved glycemic control and may help those with T1D or T2D make safe treatment decisions.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Accuracy / Adult / Aged / Algorithms / Blood Glucose / Blood Glucose Self-Monitoring / Diabetes / Diabetes Mellitus, Type 1 - drug therapy / Diabetes Mellitus, Type 2 - drug therapy / Diabetic Ketoacidosis / Enrollments / FDA approval / Glucose monitoring / glycaemic control / glycated haemoglobin / Glycated Hemoglobin / Humans / Hypoglycemia / Hypoglycemic Agents - adverse effects / Infusion pumps / Insulin / Insulin, Regular, Human / Older people / Prospective Studies