scholarly journals Effect of 6 months flash glucose monitoring in youth with type 1 diabetes and high-risk glycemic control – a randomized controlled trial

Author(s):  
Sara E Boucher ◽  
Andrew R Gray ◽  
Esko J Wiltshire ◽  
Martin I de Bock ◽  
Barbara C Galland ◽  
...  

OBJECTIVE <p>To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control.</p> <p>RESEARCH DESIGN AND METHODS</p> <p>This multi-center 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13 to 20 years with established Type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75mmol/mol). Participants were allocated to 6-month intervention (isCGM, FreeStyle Libre, Abbott; n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. </p> <p>RESULTS</p> <p>There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM, 95% CI -0.9% to 0.5% [-2.1 mmol/mol, 95% CI -9.6 to 5.4], p = 0.576). However, glucose monitoring frequency was 2.83 (95% CI 1.72 to 4.65, p < 0.001) times higher in the isCGM group compared to that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (p=0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes-specific) all p>0.1.</p> <p>CONCLUSIONS</p> <p>For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months. </p>

2020 ◽  
Author(s):  
Sara E Boucher ◽  
Andrew R Gray ◽  
Esko J Wiltshire ◽  
Martin I de Bock ◽  
Barbara C Galland ◽  
...  

OBJECTIVE <p>To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control.</p> <p>RESEARCH DESIGN AND METHODS</p> <p>This multi-center 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13 to 20 years with established Type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75mmol/mol). Participants were allocated to 6-month intervention (isCGM, FreeStyle Libre, Abbott; n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. </p> <p>RESULTS</p> <p>There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM, 95% CI -0.9% to 0.5% [-2.1 mmol/mol, 95% CI -9.6 to 5.4], p = 0.576). However, glucose monitoring frequency was 2.83 (95% CI 1.72 to 4.65, p < 0.001) times higher in the isCGM group compared to that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (p=0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes-specific) all p>0.1.</p> <p>CONCLUSIONS</p> <p>For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months. </p>


Diabetes Care ◽  
2020 ◽  
Vol 43 (10) ◽  
pp. 2388-2395 ◽  
Author(s):  
Sara E. Boucher ◽  
Andrew R. Gray ◽  
Esko J. Wiltshire ◽  
Martin I. de Bock ◽  
Barbara C. Galland ◽  
...  

2021 ◽  
Vol 1 (4) ◽  
Author(s):  
Calvin Young ◽  
Aleksandra Grobelna

Flash glucose monitoring (FGM) is a method of glucose testing where a sensor inserted into the skin continuously measures interstitial glucose levels. It can be used by people with diabetes to inform treatment decisions, such as insulin dosing, as an alternative or complement to blood glucose testing. Evidence of variable quality from 2 randomized controlled trials and 8 non-randomized studies, including those summarized within systematic reviews, suggests that FGM may improve quality of life, patient satisfaction, diabetes distress, self-efficacy, and frequency of glucose monitoring compared to self-monitoring blood glucose techniques in pediatric populations with type 1 diabetes. Findings related to other outcomes, such as hemoglobin A1C, glucose time in range metrics, and adverse events were mixed or inconclusive (i.e., in some studies the use of FGM was associated with improved outcomes, while in other studies it was not). While the results summarized in this report generally suggest that the use of FGM is associated with improved clinical outcomes in pediatric populations with type 1 diabetes, the limitations of the included literature should be considered when interpreting these findings. No studies were identified that compared the clinical effectiveness of FGM systems with hypoglycemic, hyperglycemia, or signal loss alarms (e.g., FreeStyle Libre 2) to FGM systems without these features (e.g., FreeStyle Libre) in people of any age with diabetes requiring insulin therapy.


2019 ◽  
Vol 14 (3) ◽  
pp. 567-574 ◽  
Author(s):  
Parizad Avari ◽  
Vanessa Moscardo ◽  
Narvada Jugnee ◽  
Nick Oliver ◽  
Monika Reddy

Background: The I-HART CGM study has shown that real-time continuous glucose monitoring (rtCGM) has greater beneficial impact on hypoglycemia than intermittently scanned continuous glucose monitoring (iscCGM) in adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections). In this subanalysis, we present the impact of rtCGM and iscCGM on glycemic variability (GV). Methods: Forty participants were recruited to this parallel group study. Following two weeks of blinded rtCGM (DexcomG4), participants were randomized to rtCGM (Dexcom G5; n = 20) or iscCGM (Freestyle Libre; n = 20) for eight weeks. An open-extension phase enabled participants on rtCGM to continue for a further eight weeks and those on iscCGM to switch to rtCGM over this period. Glycemic variability measures at baseline, 8- and 16-week endpoints were compared between groups. Results: At the eight-week endpoint, between-group differences demonstrated significant reduction in several GV measures with rtCGM compared to iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR]; P < .05). Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P < .05). At 16 weeks, the iscCGM group switching to rtCGM showed significant improvement in GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR. Conclusion: Our data suggest most, but not all, GV measures improve with rtCGM compared with iscCGM, particularly those measures associated with the risk of hypoglycemia. Selecting appropriate glucose monitoring technology to address GV in this high-risk cohort is important to minimize the risk of glucose extremes and severe hypoglycemia. Clinical trial registration: ClinicalTrials.gov NCT03028220


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