Switching from Flash Glucose Monitoring to Continuous Glucose Monitoring on Hypoglycemia in Adults with Type 1 Diabetes at High Hypoglycemia Risk: The Extension Phase of the I HART CGM Study

Reddy, Monika; Jugnee, Narvada; Anantharaja, Sinthuka; Oliver, Nick

doi:10.1089/dia.2018.0252

Cited by 85 publications

(103 citation statements)

References 18 publications

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“…A pilot randomized controlled study demonstrated that rtCGM but not isCGM therapy reduced exposure to hypoglycemia in patients with T1D and impaired awareness of hypoglycemia, suggesting that threshold alerts unique to rtCGM systems are important for hypoglycemia avoidance. 23,24 The current data demonstrate that the incorporation of a predictive low glucose alert into a G6 CGM system further diminishes hypoglycemia exposure, significantly reducing hypoglycemia relative to a CGM system without the predictive alert, independent of threshold alert setting. It is not surprising that users with a threshold alert setting of 80 mg/dL tended to spend less time in hypoglycemia overall compared with those with a threshold alert setting of 70 mg/dL; having a low threshold alert of 80 mg/dL provides more advanced warning to intervene before hypoglycemia.…”

Section: Discussionmentioning

confidence: 71%

Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert

Puhr

Derdzinski

Welsh

et al. 2019

Diabetes Technology & Therapeutics

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Background: Programmable and fixed auditory and/or vibratory threshold alerts are essential features of realtime continuous glucose monitoring (rtCGM) systems that provide users time to intervene before the onset of clinical hypoglycemia or hyperglycemia. A sixth-generation rtCGM system from Dexcom, Inc. (G6) includes a new alert that is triggered when an algorithm predicts that an estimated glucose value £55 mg/dL will occur within 20 min, allowing users more time to act to avoid hypoglycemia. We examined whether this predictive low glucose alert provided added benefit to traditional low threshold alerts. Methods: We analyzed glucose values from an anonymized sample of 1424 patients who transitioned to G6 from the preceding fifth-generation system (G5) with no predictive alert. Users with the low threshold alert setting of 70 or 80 mg/dL were evaluated separately. Receiver users, those who disabled the predictive low glucose alert, or those with <30 days of data immediately before or after the transition to G6 were excluded. Results: Percent time <54, £55, <70, and >250 mg/dL fell significantly after the transition to G6, independent of low threshold alert setting. Time in range improved for G6 users with a low threshold alert setting of 70 mg/dL. Conclusions: Advance warning provided by predictive low glucose alerts may further reduce hypoglycemia among rtCGM-experienced users.

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Section: Discussionmentioning

confidence: 71%

Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert

Puhr

Derdzinski

Welsh

et al. 2019

Diabetes Technology & Therapeutics

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“…The study showed that use of rtCGM more effectively reduces time spent in hypoglycemia in T1D adults with impaired hypoglycemia awareness compared with isCGM use. An extension of the IHART-CGM trial showed similar findings ( 12 ). However, there are no comparative studies regarding use of these devices during periods of physical activity or within unselected patient populations.…”

Section: Introductionmentioning

confidence: 63%

“…Change from baseline in each study phase was compared between the two interventions. On the basis of previous studies ( 8 , 12 , 16 ), we estimated 5% improvement in time below range (TBR) (<3.9 mmol/L [<70 mg/dL]) in the rtCGM group with an SD of 9% for the paired difference between study phases. Using these criteria, 28 subjects in each group (56 in total) were required to achieve the desired 80% power and an α level of 0.05 (two-tailed t test).…”

Section: Methodsmentioning

confidence: 99%

Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial

Radovnická²,

et al. 2020

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OBJECTIVE The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. RESEARCH DESIGN AND METHODS In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9–10.0 mmol/L [70–180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems. RESULTS Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM ( n = 30) or isCGM ( n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9–10 mmol/L [70–180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm. CONCLUSIONS rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.

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“…The study demonstrated, among others, a significant reduction in time spent in clinically relevant hypoglycemia (<3.3 mmol/L, 59 mg/dL) . Furthermore, an extension of this study showed that patients who switched from FGM to RT‐CGM further diminished hypoglycemic burden and improved time in range . However, reservations were made about the study's design concerning different mean absolute relative difference of the systems and our results add to uncertainty.…”

Section: Discussionmentioning

confidence: 60%

Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes

et al. 2019

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Objective: We aimed to compare glycemic control and variability parameters obtained from paired records of real-time continuous glucose monitoring (RT-CGM) and flash glucose monitoring (FGM). Methods: Ten Polish boys and 11 girls aged 15.3 ± 2.1 years with type 1 diabetes for 7.7 ± 4.5 years and glycated hemoglobin 7.35 ± 0.7% (57 ± 5 mmol/mol) were recruited between August 2017 and June 2018 and equipped with devices for RT-CGM (iPro2 system with Enlite electrodes) and FGM (FreeStyle Libre) for 1 week. Afterwards, Glyculator 2.0 software was used to calculate and compare key metrics of glycemic control listed in the International Consensus on Use of Continuous Glucose Monitoring, with distinction into all record/night-time/day-time blocks when appropriate. Results: Agreement between the two systems' measurements across patients ranged from poor (R 2 = .39) to nearly perfect (R 2 = .97). Significant differences between RT-CGM and FGM were observed in five important metrics: coefficient of variation (median difference: −4.12% [25%-75%: −7.50% to −2.96%], P = .0001), low blood glucose index (−0.88 [−1.88 to −0.18], P = .0004), % of time below 70 mg/dL (3.9 mmol/L) (−4.77 [−8.39 to −1.19], P = .0015) and 54 mg/dL (3 mmol/L) (−1.33 [−4.07 to 0.00], P = .0033) and primary time in range (TIR) 70-180 mg/dL (8.58 [1.31 to 12.66], P = .0006). Conclusions: RT-CGM and FGM differ in their estimates of clinically important indices of glycemic control. Therefore, such metrics cannot be directly compared between people using different systems. Our result necessitates system-specific guidelines and targets if TIR and glycemic variability are to be used as an endpoint in clinical trials.

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Switching from Flash Glucose Monitoring to Continuous Glucose Monitoring on Hypoglycemia in Adults with Type 1 Diabetes at High Hypoglycemia Risk: The Extension Phase of the I HART CGM Study

Cited by 85 publications

References 18 publications

Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert

Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert

Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial

Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes

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