Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics

Alexander, Charles M.; Amiel, Stephanie A.; Beck, Roy W.; Bergenstal, Richard M.; Bloomgarden, Zachary T.; Brown, Adam S.; Buckingham, Bruce A.; Cefalu, William T.; Close, Kelly L.; Chin, Isabel; Danne, Thomas; DeSalvo, Daniel J.; Ziemer, David C.; Fitts, Emily; Frier, Brian M.; Gabbay, Robert A.; Grunberger, George; Hirsch, Irl B.; Home, Philip; Kowalski, Aaron J.; Laffel, Lori M.; McCall, Anthony L.; Parkin, Christopher G.; Peters, Anne L.; Ratner, Robert E.; Schueren, Bart Van der; Wood, Richard

doi:10.2337/dci18-0010

Cited by 82 publications

(40 citation statements)

References 6 publications

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“…TIR refers to the percent time during the 24-h period when blood glucose is within the range of 70–180 mg/dl. TIR provides a more complete picture of blood glucose than HbA1c, and hence makes it possible to offer personalized treatment options [ 10 ]. Similar to HbA1c, TIR is reported to correlate strongly with the risk of retinopathy and/or onset of microalbuminuria [ 2 ].…”

Section: Discussionmentioning

confidence: 99%

Relationship between interstitial glucose variability in ambulatory glucose profile and standardized continuous glucose monitoring metrics; a pilot study

Tokutsu

Okada

Torimoto

et al. 2020

Diabetol Metab Syndr

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Background: Treatment indexes using continuous glucose monitoring (CGM) have become standardized internationally, and the use of ambulatory glucose profile (AGP) is currently recommended. However, the relationship between AGP indexes and standardized CGM metrics has not been investigated. Using flash glucose monitoring (FGM), this retrospective study served to evaluate the association of the inter-quartile range (IQR) of AGP with standardized CGM metrics. Methods: The study subjects were 30 patients with type 2 diabetes mellitus (T2DM) and 23 non-diabetic patients (control group). We evaluated average IQR (AIQR) and standardized CGM metrics. The primary endpoint was the relationship between AIQR and Time in range (TIR) in a 24-h period. Results: In the T2DM group, the AIQR was notably high and correlated negatively with TIR, and positively with Time above range, average interstitial glucose level, standard deviation of interstitial glucose, coefficient of variation of interstitial glucose, and mean of daily difference in blood glucose (MODD). For the T2DM group, the AIQR was notably lower in patients who achieved TIR > 70%, compared to those who did not. The AIQR cutoff value, as determined by ROC analysis, was 28.3 mg/dl for those who achieved TIR > 70%. No association was detected between the presence of hypoglycemia and AIQR. Conclusions: Our study is the first to provide the AIQR cutoff value for achieving the TIR target value. The range of interstitial glucose variability in AGP was associated with indexes of intra-and interday variations and hyperglycemia. Our results provide new perspectives in the yet-to-be established methods for evaluation of AGP in practical clinical settings.

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Section: Discussionmentioning

confidence: 99%

Relationship between interstitial glucose variability in ambulatory glucose profile and standardized continuous glucose monitoring metrics; a pilot study

Tokutsu

Okada

Torimoto

et al. 2020

Diabetol Metab Syndr

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“…Recent research has sought to identify and standardize the definitions of clinically meaningful outcomes beyond HbA1c in type 1 diabetes. 1,8,9 This study evaluated the preferences of people with type 1 diabetes and caregivers of children with type 1 diabetes over a set of these outcome measures, including target HbA1c, time in optimal glucose range, and number and severity of hypoglycemic and hyperglycemic events.…”

Section: Discussionmentioning

confidence: 99%

“…1 Similarly, consensus statements issued by other diabetes research organizations have emphasized the importance of a broader range of measures than HbA1c alone when considering clinical outcomes that are relevant to people with type 1 diabetes. [7][8][9] In recent years, there has been a growing recognition of the importance of incorporating patient preferences in health care decision-making. Many public and private sector organizations have developed formal processes for consulting with the patient community.…”

Section: Introductionmentioning

confidence: 99%

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<p>Preferences for Outcomes Among Adults with Type 1 Diabetes and Caregivers of Children with Type 1 Diabetes</p>

Marinac¹,

Sutphin²,

Hutton³

et al. 2020

PPA

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Point your SmartPhone at the code above. If you have a QR code reader, the video abstract will appear. Or use: https://youtu.be/zPrBA6mK5hM Purpose: Hemoglobin A1c (HbA1c) is the accepted measure of effectiveness for type 1 diabetes therapies. We investigated preferences for measures of diabetes control in addition to HbA1c among adults with type 1 diabetes and caregivers of children with type 1 diabetes. Methods: Using discrete-choice experiment methodology, surveys for adults with type 1 diabetes and caregivers presented choices between hypothetical treatments described by six attributes with varying levels: HbA1c, time in optimal glucose range, weekly number and severity of hypoglycemic and hyperglycemic events, additional disease management time, and additional treatment cost. Choice data were analyzed using random-parameters logit. Results: A total of 300 adults with type 1 diabetes and 400 caregivers completed the survey. Adults and caregivers placed the most importance on reducing hypoglycemic and hyperglycemic events. For adults, avoiding 1-5 mild-to-moderate hypoglycemic events (glucose 54-69 mg/dL)/week was five times more important than being a half-point above target HbA1c. Avoiding 1-5 hyperglycemic events (glucose >180 mg/dL)/week was seven times more important than being a half-point above target HbA1c. Additional time in optimal glucose range was as important as a reduction greater than a half-point in HbA1c. Avoiding hyperglycemic and hypoglycemic events was more important than all other outcomes for caregivers of younger children. Caregivers of children >12 years placed relatively more weight on avoiding hypoglycemic events <54 mg/dL than those with younger children and preferred avoiding additional costs. Conclusion: Adults with type 1 diabetes and caregivers prioritize controlling hypoglycemic and hyperglycemic events, including mild-to-moderate events. These preferences should be considered in drug development and regulatory decisions.

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“…Time in range (TIR) of 70–180 mg/dL (3.9–10 mmol/L) will be used as a secondary outcome to overcome the inability of HbA1c to provide information on patients’ hypoglycemia, glycemic variability, or daily patterns of glycemia [ 23 ]. TIR is a newly recognized indicator of glycemic management by both clinicians [ 23 ] and patients [ 24 ]. TIR data will be collected using a continuous glucose monitoring system (iPro2, Medtronic).…”

Section: Methodsmentioning

confidence: 99%

An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial

Huang

Xie³

et al. 2020

Trials

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Background Although evidence had demonstrated the effectiveness of smartphone apps in diabetes care, the majority of apps had been developed for type 2 diabetes mellitus (T2DM) patients and targeted at populations outside of China. The effects of applying a smartphone app with structured education on glycemic control in type 1 diabetes mellitus (T1DM) are unclear. A digital, culturally tailored structured education program was developed in a smartphone app (Yi tang yun qiao) to provide an automated, individualized education program aimed at improving self-management skills in patients with T1DM in China. This trial aims to investigate the effectiveness of this smartphone app among Chinese T1DM patients. Methods and analysis This single-blinded, 24-week, parallel-group randomized controlled trial of a smartphone app versus routine care will be conducted in Changsha, China. We plan to recruit 138 patients with T1DM who will be randomly allocated into the intervention group (automated, individualized education through an app) or routine care group. The intervention will last for 24 weeks. The primary outcome will be the change in glycated hemoglobin (HbA1c) from baseline to week 24. The secondary outcomes will include time in range, fasting blood glucose, levels of serum triglycerides and cholesterol, blood pressure, body mass index, quality of life, diabetes self-care activities, diabetes self-efficacy, depression, anxiety, and patient satisfaction. Adverse events will be formally documented. Data analysis will be conducted using the intention-to-treat principle with appropriate univariate and multivariate methods. Missing data will be imputed with a multiple imputation method under the “missing at random” assumption. Discussion This trial will investigate the effectiveness of an app-based automated structured education intervention for Chinese patients with T1DM. If the intervention is effective, this study will provide a strategy that satisfies the need for effective lifelong diabetes care to reduce the disease burden and related complications resulting from T1DM. Trial registration ClinicalTrials.gov NCT04016987. Registered on 29 October 2019.

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Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics

Cited by 82 publications

References 6 publications

Relationship between interstitial glucose variability in ambulatory glucose profile and standardized continuous glucose monitoring metrics; a pilot study

Relationship between interstitial glucose variability in ambulatory glucose profile and standardized continuous glucose monitoring metrics; a pilot study

<p>Preferences for Outcomes Among Adults with Type 1 Diabetes and Caregivers of Children with Type 1 Diabetes</p>

An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial

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