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)

Abstract

<b><i>Objective: </i></b>According to recent guidelines, individuals with type 1 diabetes should spend less than 4.0% per day with glucose levels <3.9 mmol/L (<70 mg/dL) and less than 1.0% per day <3.0 mmol/L (<54 mg/dL). <p><b><i><br> Research methods: </i></b>In the GOLD randomised cross-over trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomised 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 hypoglycaemia and various mean glucose and HbA1c levels.</p> <p> </p> <p><b><i>Results: </i></b>Time spent in hypoglycaemia (<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 hypoglycaemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycaemia <3.9 mmol/L. During CGM, mean time spent in hypoglycaemia 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% more time with glucose levels <3.9 mmol/L and 2.8% more time <3.0 mmol/L during SMBG compared with CGM.</p> <p> </p> <p><b><i>Conclusions: </i></b>Reaching current targets for time in hypoglycaemia and at the same time HbA1c targets is challenging for type 1 diabetes patients treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycaemia than SMBG at a broad range of HbA1c levels and is crucial for patients with MDI treatment to have a chance to approach hypoglycaemia targets.</p>

Glycemic Metrics Derived From Intermittently Scanned Continuous Glucose Monitoring

“…This indicates that the wisdom of attempting TIR > 70% should always be evaluated on the background of achieved GMI or mean glucose and TBR. 20 We found a curvilinear relation between TIR and GMI and recognize a similar result from a pediatric population. Mean glucose is calculated from all values (both scanned and imported every 15 min), from AUC divided by the time period, and from mean of 15 min average.…”

Leveraging advances in diabetes technologies in primary care: a narrative review

“…In a post-hoc analysis, within the CGM group, the largest HbA 1c reductions were achieved for patients with the highest baseline HbA 1c levels (!9.0%) [28]. Also, results from both the DIAMOND and GOLD studies showed that CGM use was associated with a significantly reduced time spent inand episodes ofhypoglycaemia, particularly overnight [29,30].…”

“…Real-time CGM. There is a strong evidence base showing the benefits of real-time CGM in people with diabetes receiving insulin, including the DIAMOND T1D/T2D and GOLD T1D studies [27][28][29][30][31][32]. In both the DIAMOND and GOLD studies, HbA 1c levels were significantly reduced with real-time CGM versus SMBG [31,32].…”

Hybrid Closed-Loop Systems for the Treatment of Type 1 Diabetes: A Collaborative, Expert Group Position Statement for Clinical Use in Central and Eastern Europe

“…Continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) are two diabetes technologies that have revolutionized diabetes care, with both technologies associated with improved HbA1c levels, increased TIR, and fewer hypoglycemic events compared with MDI [23][24][25][26][27][28].…”