Expert Panel Recommendations for a Standardized Ambulatory Glucose Profile Report for Connected Insulin Pens.

Background: Connected insulin pens capture data on insulin dosing/timing and can integrate with continuous glucose monitoring (CGM) devices with essential insulin and glucose metrics combined into a single platform. Standardization of connected insulin pen reports is desirable to enhance clinical utility with a single report. Methods: An international expert panel was convened to develop a standardized connected insulin pen report incorporating insulin and glucose metrics into a single report containing clinically useful information. An extensive literature review and identification of examples of current connected insulin pen reports were performed serving as the basis for creation of a draft of a standardized connected insulin pen report. The expert panel participated in three virtual standardization meetings and online surveys. Results: The Ambulatory Glucose Profile (AGP) Report: Connected Insulin Pen brings all clinically relevant CGM-derived glucose and connected insulin pen metrics into a single simplified two-page report. The first page contains the time in ranges bar, summary of key insulin and glucose metrics, the AGP curve, and detailed basal (long-acting) insulin assessment. The second page contains the bolus (mealtime and correction) insulin assessment periods with information on meal timing, insulin-to-carbohydrate ratio, average bolus insulin dose, and number of days with bolus doses recorded. The report's second page contains daily glucose profiles with an overlay of the timing and amount of basal and bolus insulin administered. Conclusion: The AGP Report: Connected Insulin Pen is a standardized clinically useful report that should be considered by companies developing connected pen technology as part of their system reporting/output.

Race and ethnicity and pharmacy dispensing of SGLT2 inhibitors and GLP-1 receptor agonists in type 2 diabetes.

Background: Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) and Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) improve cardiorenal outcomes in patients with type 2 diabetes. Equitable use of SGLT2i and GLP-1 RA has the potential to reduce racial and ethnic health disparities. We evaluated trends in pharmacy dispensing of SGLT2i and GLP-1 RA by race and ethnicity. Methods: Retrospective cohort study of patients (≥18 years) with type 2 diabetes using 2014-2022 electronic health record data from six US care delivery systems. Entry was at earliest pharmacy dispensing of any type 2 diabetes medication. We used multivariable logistic regression to evaluate the association between pharmacy dispensing of SGLT2i and GLP1-RA and race and ethnicity. Findings: Our cohort included 687,165 patients (median 6 years of dispensing data; median 60 years; 0.3% American Indian/Alaska Native (AI/AN), 16.6% Asian, 10.5% Black, 1.4% Hawaiian or Pacific Islander (HPI), 31.1% Hispanic, 3.8% Other, and 36.3% White). SGLT2i was lower for AI/AN (OR 0.80, 95% confidence interval 0.68-0.94), Black (0.89, 0.86-0.92) and Hispanic (0.87, 0.85-0.89) compared to White patients. GLP-1 RA was lower for AI/AN (0.78, 0.63-0.97), Asian (0.50, 0.48-0.53), Black (0.86, 0.83-0.90), HPI (0.52, 0.46-0.57), Hispanic (0.69, 0.66-0.71), and Other (0.78, 0.73-0.83) compared to White patients. Interpretation: Dispensing of SGLT2is, and GLP-1 RAs was lower in minority group patients. There is a need to evaluate approaches to increase use of these cardiorenal protective drugs in patients from racial and ethnic minority groups with type 2 diabetes to reduce adverse cardiorenal outcomes and improve health equity. Funding: Patient-Centered Outcomes Research Institute and National Institutes of Health.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

BACKGROUND: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. METHODS: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. RESULTS: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. CONCLUSION: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Effect of Professional CGM (pCGM) on Glucose Management in Type 2 Diabetes Patients in Primary Care.

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.

Utilizing the Ambulatory Glucose Profile to Standardize and Implement Continuous Glucose Monitoring in Clinical Practice.

Use of continuous glucose monitoring (CGM) is recognized as a valuable component of diabetes self-management and is increasingly considered a standard of care for individuals with diabetes who are treated with intensive insulin therapy. As the clinical use of CGM technology expands, consistent and standardized glycemic metrics and glucose profile visualization have become increasingly important. A common set of CGM metrics has been proposed by an international expert panel in 2017, including standard definitions of time in ranges, glucose variability, and adequacy of data collection. We describe the core CGM metrics, as well as the standardized glucose profile format consolidating 2 weeks of CGM measurements, referred to as the ambulatory glucose profile (AGP), which was also recommended by the CGM expert panel. We present an updated AGP report featuring the core CGM metrics and a visualization of glucose patterns that need clinical attention. New tools for use by clinicians and patients to interpret AGP data are reviewed. Strategies based on the authors' experience in implementing CGM technology across the clinical care spectrum are highlighted.

The Minnesota Diabetes Plan 2015: Stemming the tide on an epidemic and improving patient care.

The Minnesota Diabetes Steering Committee, a group of experts in diabetes care and prevention from around the state, in collaboration with the Minnesota Department of Health, is working to slow the incidence of diabetes and improve the care of Minnesotans who have the disease. The steering committee has developed a new five-year diabetes plan for the state that identifies nine areas around which stakeholders will focus energy and take action. This article describes that plan.

Diagnosis of insulin resistance and associated syndromes: the spectrum from the metabolic syndrome to type 2 diabetes mellitus.

Insulin resistance is a common underlying physiologic abnormality associated with central obesity, type 2 diabetes and cardiovascular disease. Clinically, its hallmark markers of hypertension, glucose intolerance and dyslipidemia have been grouped into associated syndromes of insulin resistance. Insulin resistance is now considered a useful marker of clinical risk and a target for therapeutic intervention. While the criteria for diagnosis of syndromes related to insulin resistance have been established, the clinical diagnosis of insulin resistance remains a significant challenge. As more clinicians focus on the management of insulin resistance in patients with cardiovascular disease, type 2 diabetes and other syndromes of insulin resistance, its diagnosis will take on increasing importance. This review focuses on the current definition and diagnosis of insulin resistance and associated syndromes.

Undetected, uncontrolled blood pressure in type 2 diabetes: self-monitored blood pressure profiles.

OBJECTIVES: To construct a novel and clinically relevant means of representing self-monitored blood pressure (SMBP). METHODS: Patients treated to an office blood pressure (BP) < 130/80 mmHg measured their BP at home for 14 days using an Omron IC semi-automatic portable monitor with memory. SMBP data were transferred from the monitor to a computer to produce graphic profiles (SMBPp) that depict the hourly variation in BP throughout a "typical" or modal day. RESULTS: Office BP and SMBP data from 66 subjects with type 2 diabetes and hypertension (HTN), who completed a previous study of intensified management, were analyzed based on European Society of Hypertension-European Society of Cardiology (ESH-ESC) classifications. Patients were classified as Optimal (6), Normal (12), High Normal (15), Isolated systolic HTN (29) and Grades 1, 2 or 3 HTN (4). SMBP disagreed in 32 cases, placing 29 patients in higher risk categories. Analysis by SMBPp of the 33 patients originally classified as Optimal, Normal or High Normal showed that on average 50 +/- 31% of their systolic SMBP values exceeded ESH-ESC thresholds for HTN (135 mmHg). It also revealed that 74 +/- 21% of their SMBP values exceeded the treatment goal (< 25 mmHg) for high-risk patients with type 2 diabetes. CONCLUSIONS: SMBPp allowed for a definitive measurement of the dynamic daily BP changes. It produced compelling evidence of persistent patterns of BP fluctuations among patients with normal office BP whose uncontrolled HTN would have remained undetected.