Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections

Beck, Roy W.; Riddlesworth, Tonya D; Ruedy, Katrina J.; Ahmann, Andrew J.; Haller, Stacie; Kruger, Davida F.; McGill, Janet B.; Polonsky, William H.; Price, David A.; Aronoff, Stephen L.; Aronson, Ronnie; Toschi, Elena; Kollman, Craig; Bergenstal, Richard M.

doi:10.7326/m16-2855

Cited by 453 publications

(359 citation statements)

References 29 publications

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“…Use of a CGM or an insulin pump has been shown to improve A1C [3,20,21,22••, 23] and decrease the occurrence of hypoglycemia [24, 25]. The impact of CGM use is undeniable, as demonstrated by a median reduction of 30% in hypoglycemic events in adults who use CGMs compared those who do not [24].…”

Section: Biopsychosocial Factors Associated With Cgm and Insulin Pumpmentioning

confidence: 99%

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field

et al. 2018

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Purpose of Review Summarize biopsychosocial factors associated with using continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas (AP) systems and provide a “call to the field” about their importance to technology uptake and maintained use. Recent Findings Insulin pumps and CGMs are becoming standard of care for individuals with type 1 diabetes (T1D). AP systems combining a CGM, insulin pump, and automated dosing algorithm are available for commercial use. Despite improved glycemic control with AP system use, numerous barriers exist which may limit their benefit. Studies on components of AP systems (pumps, CGMs) are limited and demonstrate mixed results of their impact on fear of hypoglycemia, adherence, quality of life, depression and anxiety, and diabetes distress. Studies examining biopsychological factors associated specifically with sustained use of AP systems are also sparse. Summary Biological, psychological and social impacts of AP systems have been understudied and the information they provide has not been capitalized upon.

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Section: Biopsychosocial Factors Associated With Cgm and Insulin Pumpmentioning

confidence: 99%

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field

et al. 2018

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“…The analysis was conducted on a data set with a median of 13 days of CGM measurements plus 39 days of fingerstick blood glucose measurements. To assess the mean glucose–HbA 1c relationship with current CGM technology and a greater amount of data, we pooled data collected in 387 participants (age range 20–78 years, 83% white, 315 with type 1 diabetes and 72 with type 2 diabetes) in three randomized trials using the Dexcom G4 Platinum CGM System with an enhanced algorithm, software 505 (Dexcom, Inc., San Diego, CA) (4,15,16). Mean glucose concentration was determined for each participant using up to 13 weeks of CGM data (median amount of CGM data 66 days) and plotted versus HbA 1c measured following the collection of the CGM data at the Northwest Lipid Research Laboratories, University of Washington, Seattle, WA, using nonporous ion exchange high-performance chromatography (TOSOH, Biosciences, Inc., South San Francisco, CA).…”

Section: Introductionmentioning

confidence: 99%

“…15, 16, and 28 (ClinicalTrials.gov identifiers NCT02282397, NCT02282397, and NCT02258373, respectively).†95% CI for a patient’s mean glucose concentration for a measured HbA 1c level.…”

Section: Introductionmentioning

confidence: 99%

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The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading

et al. 2017

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HbA1c is a valuable metric for comparing treatment groups in a randomized trial, for assessing glycemic trends in a population over time, or for cross-sectional comparisons of glycemic control in different populations. However, what is not widely appreciated is that HbA1c may not be a good indicator of an individual patient’s glycemic control because of the wide range of mean glucose concentrations and glucose profiles that can be associated with a given HbA1c level. To illustrate this point, we plotted mean glucose measured with continuous glucose monitoring (CGM) versus central laboratory–measured HbA1c in 387 participants in three randomized trials, showing that not infrequently HbA1c may underestimate or overestimate mean glucose, sometimes substantially. Thus, if HbA1c is to be used to assess glycemic control, it is imperative to know the patient’s actual mean glucose to understand how well HbA1c is an indicator of the patient’s glycemic control. With knowledge of the mean glucose, an estimated HbA1c (eA1C) can be calculated with the formula provided in this article to compare with the measured HbA1c. Estimating glycemic control from HbA1c alone is in essence applying a population average to an individual, which can be misleading. Thus, a patient’s CGM glucose profile has considerable value for optimizing his or her diabetes management. In this era of personalized, precision medicine, there are few better examples with respect to the fallacy of applying a population average to a specific patient rather than using specific information about the patient to determine the optimal approach to treatment.

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“…Several studies have shown that the use of CGM devices also improves overall glucose control and can lower long‐term hemoglobin A 1c (HbA 1c ) in diabetes mellitus patients through greater glycemic awareness (see reviews6, 7). These findings were recently confirmed in the DIAMOND trial, in which 24 weeks of CGM therapy improved glycemic control in both type 18 and type 29 diabetes mellitus patients on multiple daily insulin injections. Moreover, the American Association of Clinical Endocrinologists recommends CGM for patients at risk of hypoglycemia, T2DM patients with unappreciated hyperglycemia, and individuals using intensive insulin therapy regardless of diabetes type 10, 11.…”

mentioning

confidence: 67%

Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical Research With Type 2 Diabetes Subjects

Paglialunga

Morimoto

Peña

et al. 2018

Clinical Pharm in Drug Dev

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Continuous glucose monitoring (CGM) systems allow patients with diabetes mellitus to closely track glucose concentrations over several days, identify trends in glucose levels, and avoid glucose excursions. This technology has not only advanced diabetes mellitus management but has increased patient safety through greater glycemic awareness. Due to these attributes, CGM is now being applied in therapeutic research as a pharmacodynamic tool to support early clinical drug development programs. However, to date only a handful of studies have utilized CGM in type 2 diabetes mellitus (T2DM) drug development. A potential barrier from fostering greater use of CGM in clinical development may be related to concerns over subject variability. Therefore, we investigated a key consideration when implementing CGM into early clinical research studies: daily variation within patients with T2DM from multiple clinical research units. From 24 patients with T2DM, we observed strong daily reproducibility (Pearson R = 0.86, P < .0001) in CGM results and found that this technique is practical for multisite studies. Altogether, with low daily variability, CGM is a powerful pharmacodynamic tool for drug efficacy and safety monitoring.

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Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections

Abstract: Dexcom.

Cited by 453 publications

References 29 publications

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field

Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field

The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading

Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical Research With Type 2 Diabetes Subjects

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