The Association Between HbA1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4)

Authors: Shilan Seyed Ahmadi, Klara Westman, Aldina Pivodic, Arndís F Ólafsdóttir, Sofia Dahlqvist, Irl B Hirsch, Jarl Hellman, Magnus Ekelund, Tim Heise, William Polonsky, Magnus Wijkman, Erik Schwarcz, Marcus Lind

Abstract

Objective: According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).

Research design and methods: In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA_1c levels.

Results: Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA_1c and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA_1c <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA_1c 7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.

Conclusions: Reaching current targets for time in hypoglycemia while at the same time reaching HbA_1c targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA_1c levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.

Source: https://pubmed.ncbi.nlm.nih.gov/32641374/

Share the Post:

BDI Monthly Events

June 5 - 8: It will be a busy time at the American Diabetes Association’s 85th Scientific Sessions (New Orleans, LA), with new projects to be developed, old friends to see, and much to learn. Dr. Polonsky, BDI President, will serve a co-author on four poster presentations

May 13: BDI hosts the San Diego-wide, monthly case consultation meeting (for mental health professionals working in the field of diabetes). Contact us at [email protected] if you are in the greater San Diego area and would like further information about this program.

August 14 - 16. Taking Control of Your Diabetes (TCOYD) will be hosting the in-person ONE event, an amazing weekend experience here in San Diego for more than 500 people with type 1 diabetes and their loved ones. Dr. Polonsky is honored to be one of the presenters, and we will hope to see many of you there. There are still a few spaces left, so if you’d like to know more, please visit

On October 24, BDI will host a live, one-day, CME workshop: Engaging the Disengaged: Innovative Strategies for Promoting Behavior Change in Diabetes. Run by Dr. Polonsky (BDI President) and Dr. Guzman (BDI Clinic Director), Participants will deepen their skills in recognizing and addressing common barriers to effective self-care and cardiometabolic medication initiation and maintenance, while fostering respectful, stigma-free clinical encounters.