scholarly journals The association between HbA1c and time in hypoglycaemia during CGM and self-monitoring of blood glucose in persons with type 1 diabetes and multiple daily insulin injections: A Randomised Clinical Trial (GOLD-study 4)

Author(s):  
Shilan Seyed Ahmadi ◽  
Klara Westman ◽  
Aldina Pivodic ◽  
Arndís F Ólafsdóttir ◽  
Sofia Dahlqvist ◽  
...  

<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>

2020 ◽  
Author(s):  
Shilan Seyed Ahmadi ◽  
Klara Westman ◽  
Aldina Pivodic ◽  
Arndís F Ólafsdóttir ◽  
Sofia Dahlqvist ◽  
...  

<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>


2020 ◽  
Author(s):  
Shilan Seyed Ahmadi ◽  
Klara Westman ◽  
Aldina Pivodic ◽  
Arndís F Ólafsdóttir ◽  
Sofia Dahlqvist ◽  
...  

<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>


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Lindsey L Owens ◽  
Sweta Chalise ◽  
Neha Vyas ◽  
Shilpa Gurnurkar

Abstract Introduction: Type 1 diabetes is an autoimmune condition resulting in insulin deficiency that requires daily insulin therapy and self-monitoring of blood glucose. Continuous glucose monitoring (CGM) systems allow for measurement of interstitial fluid glucose levels in a continuous fashion to identify variations and trends that are not feasible with conventional self-monitoring. Hemoglobin A1C (HbA1C) is the method used to assess adequate glycemic control and relates to future risk of developing complications. Current evidence has shown improvement in HbA1C with concomitant use of CGM in adults over 25 years of age with Type 1 diabetes, whereas studies in children and adolescents have failed to show this. However, it is important to note the limitations in HbA1C use as it is a marker of average blood glucose over 3 months but does not reflect glycemic variability. More recent data has suggested that factors such as time in range (TIR), which can be determined with CGM use, are also associated with decrease risk of diabetes complications. Methods: The goal of our study was to analyze the change in HbA1C levels after using a CGM (DEXCOM G4, G5, G6) over a 6-month period in pediatric patients with Type I diabetes. Two HBA1c levels 3 months apart from 92 patients were collected before using a CGM and two while using a CGM. Results were compared by using a dependent samples t-test. IBM SPSS 25.0 was used for data analysis. Results: Preliminary analysis indicates the average change in HBA1C among the patients (N=92) before (-0.08 ± 1.16) and while using the CGM (0.12 ± 1.00) was not significantly different (t (79) = -1.27, p = 0.21). The average change in HBA1C was also not significantly different (p&gt;0.05) among the patients before and while using the CGM for gender (males and females), age groups (0-7 years, 8-14 years, and 15-24 years), and generations of DEXCOM used (G4, G5, and G6). Conclusion: As has been shown in other studies, we did not find a significant change in HbA1c after CGM use for 6 months in our patients. While HbA1C is a reflection of blood sugars over a 3-month period, it does not provide information about glycemic excursions. Metrics derived from CGM use, such as TIR, can provide actionable information which we did not address in our study. There have been reports of the association between TIR and long-term complications of diabetes. Most data comes from studies in adults and pediatric data is lacking. We propose that future studies must look into CGM metrics such as TIR to better define glycemic control in pediatric patients with diabetes mellitus.


Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 776-P
Author(s):  
RACHEL BRANDT ◽  
MINSUN PARK ◽  
LAURIE T. QUINN ◽  
MINSEUNG CHU ◽  
YOUNGKWAN SONG ◽  
...  

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