66-OR: Effect of Time-in-Range over 14 Days on Glycaemic Controls and Hypoglycaemia Unawareness in Patients Using Freestyle Libre

Abstract There are no large-scale studies on the association between time in range (TIR) and hemoglobin A1c (HbA1c) in Japanese patients with type 2 diabetes mellitus (T2DM) only. The aim of this study was to define the relationship between TIR and HbA1c levels in Japanese patients with T2DM. The glycemic profile of 999 patients was analyzed with FreeStyle Libre Pro Continuous Glucose Monitoring (FLP-CGM) while they continued their prescribed glucose-lowering medications. FLP-CGM data recorded over 8 consecutive days were analyzed. The regression model for HbA1c on TIR was HbA1c = 9.4966 − 0.0309×TIR. The predicted HbA1c level for TIR of 70% was 7.33%, and is higher than recent reports subjecting mostly T1DM. The TIR corresponding to HbA1c 7.0% was 80.64%. HbA1c level correlated significantly with many FLP-CGM-derived metrics. The patients with low TIR tended to have long history of diabetes, on higher daily insulin dose and had high body mass index, HbA1c, liver dysfunction and triglyceride. Furthermore, relatively higher percentages of patients of this group used sulfonylureas, glinides, glucagon like peptide-1 receptor agonists and insulin. Our data showed that the predicted HbA1c corresponding to TIR is largely depends on the study population, thus is not uniform. Our results provide new insights on the management of T2DM.

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Glucose Regulation Beyond HbA1c in Type 2 Diabetes Treated With Insulin: Real-World Evidence From the DIALECT-2 Cohort

10.2337/figshare.14838837.v1 ◽

2021 ◽

Author(s):

Niala den Braber ◽

Miriam M.R. Vollenbroek-Hutten ◽

Kathryn M. Westerik ◽

Stephan J.L. Bakker ◽

Gerjan Navis ◽

...

Keyword(s):

Type 2 Diabetes ◽

Glucose Monitoring ◽

Glucose Variability ◽

Glucose Regulation ◽

Nocturnal Hypoglycemia ◽

Real World Evidence ◽

Freestyle Libre ◽

Time In Range ◽

Design And Methods

OBJECTIVE To investigate glucose variations associated with HbA1c in insulin treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Patients included in the Diabetes and Lifestyle Cohort Twente (DIALECT)-2 (n=79) were categorized in three HbA1c categories: low, intermediate and high (≤ 53; 54–62 and ≥ 63 mmol/mol or ≤ 7, 7.1–7.8, ≥ 7.9%). Blood glucose time in range (TIR), time below range (TBR), time above range (TAR), glucose variability parameters, day and night duration and frequency of TBR and TAR episodes were determined by continuous glucose monitoring (CGM), using the FreeStyle Libre sensor and compared between HbA1c categories. RESULTS <a>CGM was performed for a median [interquartile range] of 10 [7-12] days/ patient. </a>TIR was not different for low and intermediate HbA1c categories: (76.8% [68.3–88.2] vs 76.0% [72.5.0–80.1]), whereas in the low category TBR was higher and TAR lower (7.7% [2.4–19.1] vs 0.7% [0.3–6.1], and 8.2% [5.7–17.6] vs 20.4% [11.6–27.0], respectively, p < 0.05). Patients in the highest HbA1c category had lower TIR (52.7% [40.9–67.3]) and higher TAR (44.1% [27.8–57.0]) than the other HbA1c categories (p < 0.05), but did not have less TBR during the night. All patients had more (0.06 ± 0.06/h vs 0.03 ± 0.03/h, p = 0.002) and longer (88.0 [45.0–195.5] vs 53.4 [34.4–82.8] minutes, p < 0.001) TBR episodes during the night than during the day. CONCLUSIONS In this study, a high HbA1c did not reduce the occurrence of nocturnal hypoglycemia and low HbA1c was not associated with the highest TIR. Optimal personalization of glycemic control requires the use of newer tools, including CGM-derived parameters.

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Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa076 ◽

2020 ◽

Vol 4 (9) ◽

Author(s):

Robin L Gal ◽

Nathan J Cohen ◽

Davida Kruger ◽

Roy W Beck ◽

Richard M Bergenstal ◽

...

Keyword(s):

Quality Of Life ◽

Glycemic Control ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Diabetes Distress ◽

Quality Of Life Indicators ◽

Freestyle Libre ◽

Time In Range

Abstract The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A1c (HbA1c) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA1c decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks (P < .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% (P < .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.

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Real-time CGM is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 diabetes: The CORRIDA Randomized Control Trial

10.2337/figshare.12767927.v1 ◽

2020 ◽

Author(s):

Aneta Hásková ◽

Lucie Radovnická ◽

Lenka Petruželková ◽

Christopher G. Parkin ◽

George Grunberger ◽

...

Keyword(s):

Real Time ◽

Randomized Study ◽

Glucose Monitoring ◽

Self Management ◽

Flash Glucose Monitoring ◽

Primary Endpoints ◽

Freestyle Libre ◽

Time In Range ◽

Randomized Control

Background: The aim of this trial was to compare the efficacy of real-time and <a>intermittently-scanned </a>continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. Methods: <a>In this randomized study, adults with T1D and normal hypoglycemia</a> awareness (GOLD score <4) used rtCGM (Guardian Connect Mobile) or isCGM (Freestyle Libre) during 4 days of physical activity (exercise phase) and in subsequent 4 weeks at home (home phase). Primary endpoints 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 vs. 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.<a></a> Conclusion: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in T1D adults with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.

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Glucose Regulation Beyond HbA1c in Type 2 Diabetes Treated With Insulin: Real-World Evidence From the DIALECT-2 Cohort

10.2337/figshare.14838837 ◽

2021 ◽

Author(s):

Niala den Braber ◽

Miriam M.R. Vollenbroek-Hutten ◽

Kathryn M. Westerik ◽

Stephan J.L. Bakker ◽

Gerjan Navis ◽

...

Keyword(s):

Type 2 Diabetes ◽

Glucose Monitoring ◽

Glucose Variability ◽

Glucose Regulation ◽

Nocturnal Hypoglycemia ◽

Real World Evidence ◽

Freestyle Libre ◽

Time In Range ◽

Design And Methods

OBJECTIVE To investigate glucose variations associated with HbA1c in insulin treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Patients included in the Diabetes and Lifestyle Cohort Twente (DIALECT)-2 (n=79) were categorized in three HbA1c categories: low, intermediate and high (≤ 53; 54–62 and ≥ 63 mmol/mol or ≤ 7, 7.1–7.8, ≥ 7.9%). Blood glucose time in range (TIR), time below range (TBR), time above range (TAR), glucose variability parameters, day and night duration and frequency of TBR and TAR episodes were determined by continuous glucose monitoring (CGM), using the FreeStyle Libre sensor and compared between HbA1c categories. RESULTS <a>CGM was performed for a median [interquartile range] of 10 [7-12] days/ patient. </a>TIR was not different for low and intermediate HbA1c categories: (76.8% [68.3–88.2] vs 76.0% [72.5.0–80.1]), whereas in the low category TBR was higher and TAR lower (7.7% [2.4–19.1] vs 0.7% [0.3–6.1], and 8.2% [5.7–17.6] vs 20.4% [11.6–27.0], respectively, p < 0.05). Patients in the highest HbA1c category had lower TIR (52.7% [40.9–67.3]) and higher TAR (44.1% [27.8–57.0]) than the other HbA1c categories (p < 0.05), but did not have less TBR during the night. All patients had more (0.06 ± 0.06/h vs 0.03 ± 0.03/h, p = 0.002) and longer (88.0 [45.0–195.5] vs 53.4 [34.4–82.8] minutes, p < 0.001) TBR episodes during the night than during the day. CONCLUSIONS In this study, a high HbA1c did not reduce the occurrence of nocturnal hypoglycemia and low HbA1c was not associated with the highest TIR. Optimal personalization of glycemic control requires the use of newer tools, including CGM-derived parameters.

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Real-time CGM is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 diabetes: The CORRIDA Randomized Control Trial

10.2337/figshare.12767927 ◽

2020 ◽

Author(s):

Aneta Hásková ◽

Lucie Radovnická ◽

Lenka Petruželková ◽

Christopher G. Parkin ◽

George Grunberger ◽

...

Keyword(s):

Real Time ◽

Randomized Study ◽

Glucose Monitoring ◽

Self Management ◽

Flash Glucose Monitoring ◽

Primary Endpoints ◽

Freestyle Libre ◽

Time In Range ◽

Randomized Control

Background: The aim of this trial was to compare the efficacy of real-time and <a>intermittently-scanned </a>continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. Methods: <a>In this randomized study, adults with T1D and normal hypoglycemia</a> awareness (GOLD score <4) used rtCGM (Guardian Connect Mobile) or isCGM (Freestyle Libre) during 4 days of physical activity (exercise phase) and in subsequent 4 weeks at home (home phase). Primary endpoints 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 vs. 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.<a></a> Conclusion: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in T1D adults with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.

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AGP in daily clinical practice: a guide for use with the FreeStyle Libre flash glucose monitoring system

British Journal of Diabetes ◽

10.15277/bjd.2020.240 ◽

2020 ◽

Vol 20 (1) ◽

pp. 32-40 ◽

Cited By ~ 1

Author(s):

Fraser W Gibb ◽

Peter Jennings ◽

Lalantha Leelarathna ◽

Emma G Wilmot

Keyword(s):

Monitoring System ◽

Glucose Control ◽

Glucose Monitoring ◽

Monitoring Systems ◽

Flash Glucose Monitoring ◽

Diabetes Outcomes ◽

Freestyle Libre ◽

Time In Range ◽

Practical Guidance ◽

Flash Glucose Monitoring System

As real-time continuous glucose monitoring and flash glucose monitoring systems become more widely prescribed in the daily management of diabetes, it is important that the ambulatory glucose profile (AGP) methodology for reviewing and interpreting trends in glucose control is effectively applied. In this article we look at the essential features of the AGP and provide systematic and practical guidance on how the AGP can be interpreted in daily diabetes care with confidence. Using examples taken from glucose data captured by the FreeStyle Libre flash glucose monitoring system, we show how each aspect of the AGP can be used to understand daily patterns in glucose control for a person with diabetes, including the importance of time in range and adjunct use of individual daily logs. Using these elements collectively, we show how and why treatment adjustments can be made, with the goal of improving glycaemic control and diabetes outcomes.

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Exploring the inter-subject variability in the relationship between glucose monitoring metrics and glycated hemoglobin for pediatric patients with type 1 diabetes

Journal of Pediatric Endocrinology and Metabolism ◽

10.1515/jpem-2020-0725 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Pietro Bosoni ◽

Valeria Calcaterra ◽

Valentina Tibollo ◽

Alberto Malovini ◽

Gianvincenzo Zuccotti ◽

...

Keyword(s):

Type 1 Diabetes ◽

Glycated Hemoglobin ◽

Glucose Monitoring ◽

Daily Injection ◽

Target Range ◽

Freestyle Libre ◽

Subject Variability ◽

Time In Range ◽

The Relationship

Abstract Objectives Despite the widespread diffusion of continuous glucose monitoring (CGM) systems, which includes both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), an effective application of CGM technology in clinical practice is still limited. The study aimed to investigate the relationship between isCGM-derived glycemic metrics and glycated hemoglobin (HbA1c), identifying overall CGM targets and exploring the inter-subject variability. Methods A group of 27 children and adolescents with type 1 diabetes under multiple daily injection insulin-therapy was enrolled. All participants used the isCGM Abbott’s FreeStyle Libre system on average for eight months, and clinical data were collected from the Advanced Intelligent Distant-Glucose Monitoring platform. Starting from each HbA1c exam date, windows of past 30, 60, and 90 days were considered to compute several CGM metrics. The relationships between HbA1c and each metric were explored through linear mixed models, adopting an HbA1c target of 7%. Results Time in Range and Time in Target Range show a negative relationship with HbA1c (R2>0.88) whereas Time Above Range and Time Severely Above Range show a positive relationship (R2>0.75). Focusing on Time in Range in 30-day windows, random effect represented by the patient’s specific intercept reveals a high variability compared to the overall population intercept. Conclusions This study confirms the relationship between several CGM metrics and HbA1c; it also highlights the importance of an individualized interpretation of the CGM data.

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