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 HbA1c levels.

Results: Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA1c and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA1c <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 HbA1c 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 HbA1c 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 HbA1c 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/

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BDI Monthly Events

March 12Case Consultation Meeting
March 12: 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.
March 19-22International Conference
18th International Conference for ATTD (Advanced Technologies and Treatments for Diabetes) in Amsterdam, Dr. Polonsky (BDI President) has three presentations.
March 19Type 2 Presentation
On March 19, Dr. Polonski will present CGM is Wonderful, But… at the Roche-sponsored symposium, “Translating the Power of Prediction into Diabetes Management”, and Insulin Therapy Experience: Considering the Needs of People Living with Diabetes (with Professor Cukierman-Yaffe) at the Sanofi-sponsored symposium, Confidence and Simplicity in Diabetes Management”. https://attd.kenes.com/
March 20Type 2 Presentation
On March 20, Dr. Polonski will present Improved Patient- and Physician-Reported Outcomes with IGlarLixi When Switching From Premixed Insulin in People with Type 2 Diabetes: The Soli-Switch Study. https://cslide.ctimeetingtech.com/attd25/attendee/confcal/session/calendar/2025-03-20