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

2021 ◽  
Author(s):  
Niala den Braber ◽  
Miriam M.R. Vollenbroek-Hutten ◽  
Kathryn M. Westerik ◽  
Stephan J.L. Bakker ◽  
Gerjan Navis ◽  
...  

OBJECTIVE To investigate glucose variations associated with HbA<sub>1c</sub> in insulin treated patients with type 2 diabetes. <p>RESEARCH DESIGN AND METHODS Patients included in the Diabetes and Lifestyle Cohort Twente (DIALECT)-2 (n=79) were categorized in three HbA<sub>1c</sub> 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 HbA<sub>1c</sub> categories.</p> <p>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 HbA<sub>1c</sub> categories:<sub> </sub>(76.8% [68.3–88.2] vs 76.0% [72.5.0–80.1]), whereas in the low category<sub> </sub>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, <i>p </i>< 0.05). Patients in the highest HbA<sub>1c </sub>category had lower TIR (52.7% [40.9–67.3]) and higher TAR (44.1% [27.8–57.0]) than the other HbA<sub>1c </sub>categories (<i>p</i> < 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, <i>p </i>= 0.002) and longer (88.0 [45.0–195.5] vs 53.4 [34.4–82.8] minutes, <i>p </i>< 0.001) TBR episodes during the night than during the day. </p> <p>CONCLUSIONS In this study, a high HbA<sub>1c</sub> did not reduce the occurrence of nocturnal hypoglycemia and low HbA<sub>1c</sub> was not associated with the highest TIR. Optimal personalization of glycemic control requires the use of newer tools, including CGM-derived parameters. <br> </p>

2021 ◽  
Author(s):  
Niala den Braber ◽  
Miriam M.R. Vollenbroek-Hutten ◽  
Kathryn M. Westerik ◽  
Stephan J.L. Bakker ◽  
Gerjan Navis ◽  
...  

OBJECTIVE To investigate glucose variations associated with HbA<sub>1c</sub> in insulin treated patients with type 2 diabetes. <p>RESEARCH DESIGN AND METHODS Patients included in the Diabetes and Lifestyle Cohort Twente (DIALECT)-2 (n=79) were categorized in three HbA<sub>1c</sub> 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 HbA<sub>1c</sub> categories.</p> <p>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 HbA<sub>1c</sub> categories:<sub> </sub>(76.8% [68.3–88.2] vs 76.0% [72.5.0–80.1]), whereas in the low category<sub> </sub>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, <i>p </i>< 0.05). Patients in the highest HbA<sub>1c </sub>category had lower TIR (52.7% [40.9–67.3]) and higher TAR (44.1% [27.8–57.0]) than the other HbA<sub>1c </sub>categories (<i>p</i> < 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, <i>p </i>= 0.002) and longer (88.0 [45.0–195.5] vs 53.4 [34.4–82.8] minutes, <i>p </i>< 0.001) TBR episodes during the night than during the day. </p> <p>CONCLUSIONS In this study, a high HbA<sub>1c</sub> did not reduce the occurrence of nocturnal hypoglycemia and low HbA<sub>1c</sub> was not associated with the highest TIR. Optimal personalization of glycemic control requires the use of newer tools, including CGM-derived parameters. <br> </p>


2019 ◽  
Vol 120 (1) ◽  
pp. 171-179 ◽  
Author(s):  
Aye C. Paing ◽  
Kathryn A. McMillan ◽  
Alison F. Kirk ◽  
Andrew Collier ◽  
Allan Hewitt ◽  
...  

Abstract Purpose To investigate how the pattern of sedentary behaviour affects intra-day glucose regulation in type 2 diabetes. Methods This intensive longitudinal study was conducted in 37 participants with type 2 diabetes (age, 62.8 ± 10.5 years). Glucose and sedentary behaviour/physical activity were assessed with a continuous glucose monitoring (Abbott FreeStyle Libre) and an activity monitor (activPAL3) for 14 days. Multiple regression models with generalised estimating equations (GEEs) approach were used to assess the associations of sedentary time and breaks in sedentary time with pre-breakfast glucose, pre-lunch glucose, pre-dinner glucose, post-breakfast glucose, post-lunch glucose, post-dinner glucose, bedtime glucose, the dawn phenomenon, time in target glucose range (TIR, glucose 3.9–10 mmol/L) and time above target glucose range (TAR, glucose > 10 mmol/L). Results Sedentary time was associated with higher pre-breakfast glucose (p = 0.001), pre-dinner glucose (p < 0.001), post-lunch glucose (p = 0.005), post-dinner glucose (p = 0.013) and the dawn phenomenon (p < 0.001). Breaks in sedentary time were associated with lower pre-breakfast glucose (p = 0.023), pre-dinner glucose (p = 0.023), post-breakfast glucose (p < 0.001) and the dawn phenomenon (p = 0.004). The association between sedentary time and less TIR (p = 0.022) and the association between breaks in sedentary time and more TIR (p = 0.001) were also observed. Conclusions Reducing sedentary time and promoting breaks in sedentary time could be clinically relevant to improve intra-day glucose regulation in type 2 diabetes.


2018 ◽  
Vol 25 (1) ◽  
pp. 99-103
Author(s):  
Simona Clus ◽  
Gabriela Crețeanu ◽  
Amorin Popa

Abstract Background and aims: It is known that the majority of critical unacknowledged hypoglycemia has an increased incidence in patients with type 1 diabetes (T1DM) with a long evolution. The aim of this research is to evaluate the variability of glucose level and hypoglycemic events in patients with type 2 diabetes (T2DM) having pharmacological interventions with hypoglycemic risk. These events are sometimes asymptomatic also in T2DM: frequently in elderly, patients with autonomic neuropathy, or having a long evolution of disease. Material and method: This analysis includes 72 patients with T2DM, with a relative good metabolic control, and possible glucose fluctuations. Glucose variability was appreciated using continuous glucose monitoring systems (CGMS) used for more than 72 hours in hospital or ambulatory setting. Results: The incidence, duration and severity of hypoglycemia are not correlated with HbA1c value, age, disease duration or treatment. Approximately a quarter of patients had nocturnal hypoglycemia and in 37,5% of events hypoglycemia was prolonged, more 45 minutes. Clinical manifestations in diurnal hypoglycemia were presents in only 40% of the recorded events. Conclusions: The study suggested that CGMS is beneficial for patients with type 2 diabetes, with hypoglycemic risk and complications, to adjusted medication, education and prevention the cardiovascular events.


2021 ◽  
Author(s):  
Grazia Aleppo ◽  
Roy W. Beck ◽  
Ryan Bailey ◽  
Katrina J. Ruedy ◽  
Peter Calhoun ◽  
...  

<b>Objective: </b>To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin. <p><b>Research Design and Methods:</b> Multi-center trial with an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months, followed by 6 months in which the BGM Group continued to use BGM (N=57) and the CGM Group was re-randomized either to continue CGM (N=53) or discontinue CGM with resumption of BGM for glucose monitoring (N=53). </p> <p><b>Results: </b>In the group that discontinued CGM, mean time in range 70-180 mg/dL (TIR), which improved from 38% prior to initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months = -12%, 95% CI -21% to -3%, P=0.01). In the group continuing CGM, there was little change in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%; mean change 8 to 14 months = 1%, 95% CI -11% to 12%, P=0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was -6% (95% CI -16% to 4%, P=0.20).</p> <p><b>Conclusions: </b>In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about half of the initial gain in TIR that had been achieved during CGM use.</p>


2021 ◽  
Author(s):  
Grazia Aleppo ◽  
Roy W. Beck ◽  
Ryan Bailey ◽  
Katrina J. Ruedy ◽  
Peter Calhoun ◽  
...  

<b>Objective: </b>To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin. <p><b>Research Design and Methods:</b> Multi-center trial with an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months, followed by 6 months in which the BGM Group continued to use BGM (N=57) and the CGM Group was re-randomized either to continue CGM (N=53) or discontinue CGM with resumption of BGM for glucose monitoring (N=53). </p> <p><b>Results: </b>In the group that discontinued CGM, mean time in range 70-180 mg/dL (TIR), which improved from 38% prior to initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months = -12%, 95% CI -21% to -3%, P=0.01). In the group continuing CGM, there was little change in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%; mean change 8 to 14 months = 1%, 95% CI -11% to 12%, P=0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was -6% (95% CI -16% to 4%, P=0.20).</p> <p><b>Conclusions: </b>In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about half of the initial gain in TIR that had been achieved during CGM use.</p>


2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Marcio Krakauer ◽  
Jose Fernando Botero ◽  
Fernando J. Lavalle-González ◽  
Adrian Proietti ◽  
Douglas Eugenio Barbieri

Abstract Background Continuous glucose monitoring systems are increasingly being adopted as an alternative to self-monitoring of blood glucose (SMBG) by persons with diabetes mellitus receiving insulin therapy. Main body The FreeStyle Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, United Kingdom) consists of a factory-calibrated sensor worn on the back of the arm which measures glucose levels in the interstitial fluid every minute and stores the reading automatically every 15 min. Swiping the reader device over the sensor retrieves stored data and displays current interstitial glucose levels, a glucose trend arrow, and a graph of glucose readings over the preceding 8 h. In patients with type 2 diabetes (T2D) receiving insulin therapy, pivotal efficacy data were provided by the 6-month REPLACE randomized controlled trial (RCT) and 6-month extension study. Compared to SMBG, the flash system significantly reduced the time spent in hypoglycemia and frequency of hypoglycemic events, although no significant change was observed in glycosylated hemoglobin (HbA1c) levels. Subsequent RCTs and real-world chart review studies have since shown that flash glucose monitoring significantly reduces HbA1c from baseline. Real-world studies in both type 1 diabetes or T2D populations also showed that flash glucose monitoring improved glycemic control. Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range. Additional benefits associated with flash glucose monitoring versus SMBG include reductions in acute diabetes events, all-cause hospitalizations and hospitalized ketoacidosis episodes; improved well-being and decreased disease burden; and greater treatment satisfaction. Conclusion T2D patients who use flash glucose monitoring might expect to achieve significant improvement in HbA1c and glycemic parameters and several associated benefits.


2021 ◽  
pp. 193229682199872
Author(s):  
Gregg D. Simonson ◽  
Richard M. Bergenstal ◽  
Mary L. Johnson ◽  
Janet L. Davidson ◽  
Thomas W. Martens

Background: Little data exists regarding the impact of continuous glucose monitoring (CGM) in the primary care management of type 2 diabetes (T2D). We initiated a quality improvement (QI) project in a large healthcare system to determine the effect of professional CGM (pCGM) on glucose management. We evaluated both an MD and RN/Certified Diabetes Care and Education Specialist (CDCES) Care Model. Methods: Participants with T2D for >1 yr., A1C ≥7.0% to <11.0%, managed with any T2D regimen and willing to use pCGM were included. Baseline A1C was collected and participants wore a pCGM (Libre Pro) for up to 2 weeks, followed by a visit with an MD or RN/CDCES to review CGM data including Ambulatory Glucose Profile (AGP) Report. Shared-decision making was used to modify lifestyle and medications. Clinic follow-up in 3 to 6 months included an A1C and, in a subset, a repeat pCGM. Results: Sixty-eight participants average age 61.6 years, average duration of T2D 15 years, mean A1C 8.8%, were identified. Pre to post pCGM lowered A1C from 8.8% ± 1.2% to 8.2% ± 1.3% (n=68, P=0.006). The time in range (TIR) and time in hyperglycemia improved along with more hypoglycemia in the subset of 37 participants who wore a second pCGM. Glycemic improvement was due to lifestyle counseling (68% of participants) and intensification of therapy (65% of participants), rather than addition of medications. Conclusions: Using pCGM in primary care, with an MD or RN/CDCES Care Model, is effective at lowering A1C, increasing TIR and reducing time in hyperglycemia without necessarily requiring additional medications.


2021 ◽  
Vol 9 (1) ◽  
pp. e002057
Author(s):  
Alexander S Atkin ◽  
Abu Saleh Md Moin ◽  
Ahmed Al-Qaissi ◽  
Thozhukat Sathyapalan ◽  
Stephen L Atkin ◽  
...  

IntroductionGlucose variability is associated with mortality and macrovascular diabetes complications. The mechanisms through which glucose variability mediates tissue damage are not well understood, although cellular oxidative stress is likely involved. As heat shock proteins (HSPs) play a role in the pathogenesis of type 2 diabetes (T2D) complications and are rapidly responsive, we hypothesized that HSP-related proteins (HSPRPs) would differ in diabetes and may respond to glucose normalization.Research design and methodsA prospective, parallel study in T2D (n=23) and controls (n=23) was undertaken. T2D subjects underwent insulin-induced blood glucose normalization from baseline 7.6±0.4 mmol/L (136.8±7.2 mg/dL) to 4.5±0.07 mmol/L (81±1.2 mg/dL) for 1 hour. Control subjects were maintained at 4.9±0.1 mmol/L (88.2±1.8 mg/dL). Slow Off-rate Modified Aptamer-scan plasma protein measurement determined a panel of HSPRPs.ResultsAt baseline, E3-ubiquitin-protein ligase (carboxyl-terminus of Hsc70 interacting protein (CHIP) or HSPABP2) was lower (p=0.03) and ubiquitin-conjugating enzyme E2G2 higher (p=0.003) in T2D versus controls. Following glucose normalization, DnaJ homolog subfamily B member 1 (DNAJB1 or HSP40) was reduced (p=0.02) in T2D, with HSP beta-1 (HSPB1) and HSP-70-1A (HSP70-1A) (p=0.07 and p=0.09, respectively) also approaching significance relative to T2D baseline levels.ConclusionsKey HSPRPs involved in critical protein interactions, CHIP and UBE2G2, were altered in diabetes at baseline. DNAJB1 fell in response to euglycemia, suggesting that HSPs are reacting to basal stress that could be mitigated by tight glucose control with reduction of glucose variability.


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