OBJECTIVE: The purpose of this study was to assess factors associated with patient frequency of intentionally skipping insulin injections. RESEARCH DESIGN AND METHODS: Data were obtained through an ...Internet survey of 502 U.S. adults self-identified as taking insulin by injection to treat type 1 or type 2 diabetes. Multiple regression analysis assessed independent associations of various demographic, disease, and injection-specific factors with insulin omission. RESULTS: Intentional insulin omission was reported by more than half of respondents; regular omission was reported by 20%. Significant independent risk factors for insulin omission were younger age, lower income and higher education, type 2 diabetes, not following a healthy diet, taking more daily injections, interference of injections with daily activities, and injection pain and embarrassment. Risk factors differed between type 1 and type 2 diabetic patients, with diet nonadherence more prominent in type 1 diabetes and age, education, income, pain, and embarrassment more prominent in type 2 diabetes. CONCLUSIONS: Whereas most patients did not report regular intentional omission of insulin injections, a substantial number did. Our findings suggest that it is important to identify patients who intentionally omit insulin and be aware of the potential risk factors identified here. For patients who report injection-related problems (interference with daily activities, injection pain, and embarrassment), providers should consider recommending strategies and tools for addressing these problems to increase adherence to prescribed insulin regimens. This could improve clinical outcomes.
Recent studies have demonstrated the clinical utility of continuous glucose monitoring (CGM) use in type 2 diabetes (T2D) patients who are treated with intensive insulin management. Large ...retrospective database analyses of T2D patients treated with less-intensive therapies have also shown that CGM use was associated with significant reductions in hemoglobin A1c levels and health resource utilization, including diabetes-related hospitalizations and emergency room care. Despite the growing body of evidence supporting CGM use in the broader T2D population, current eligibility criteria required by public and many private insurers are denying millions of individuals with T2D access to this valuable technology. In this article, we discuss an evidence-based rationale for modifying current eligibility requirements for CGM coverage.
To determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults ...with well-controlled type 1 diabetes (T1D).
A randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were ≥18 years of age (mean 44 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA
≤9.0% (≤75 mmol/mL) (mean 7.0 ± 0.7% 53 ± 7.7 mmol/mol); prestudy, 47% were CGM users. Participants were randomly assigned 2:1 to the CGM-only (
= 149) or CGM+BGM (
= 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%.
CGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 ± 0.9 and 5.4 ± 1.4 in the two groups, respectively (
< 0.001). Mean time in 70-180 mg/dL was 63 ± 13% at both baseline and 26 weeks in the CGM-only group and 65 ± 13% and 65 ± 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group.
Use of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia.
Abstract Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic ...control among individuals with type 1 diabetes. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardization of analysis and presentation of glucose monitoring data, with the initial focus on data derived from CGM systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile (AGP), and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings. This paper provides a summary of the topics and issues discussed during the meeting and presents recommendations from the expert panel regarding the need to standardize glucose profile summary metrics and the value of a uniform glucose report to aid clinicians, researchers, and patients.
Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin ...Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine the appropriate next insulin dose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone.
In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21–70 years, diagnosed with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58 mmol/mol) and 11% or lower (≤97 mmol/mol), and had been using the same insulin regimen for the previous 3 months. Exclusion criteria included body-mass index of 45 kg/m2 or higher; severe cardiac, hepatic, or renal impairment; and more than two severe hypoglycaemic events in the past year. Eligible participants were randomly assigned (1:1), with randomisation blocked within each site, to either d-Nav and health-care professional support (intervention group) or health-care professional support alone (control group). Both groups were contacted seven times (three face-to-face and four phone visits) during 6 months of follow-up. The primary objective was to compare average change in HbA1c from baseline to 6 months. Safety was assessed by the frequency of hypoglycaemic events. The primary objective and safety were assessed in the intention-to-treat population. We used Student's t test to assess the primary outcome for statistical significance. This study was registered with ClinicalTrials.gov, number NCT02424500.
Between Feb 2, 2015, and March 17, 2017, 236 patients were screened for eligibility, of whom 181 (77%) were enrolled and randomly assigned to the intervention (n=93) and control (n=88) groups. At baseline, mean HbA1c was 8·7% (SD 0·8; 72 mmol/mol SD 8·8) in the intervention group and 8·5% (SD 0·8; 69 mmol/mol SD 8·8) in the control group. The mean decrease in HbA1c from baseline to 6 months was 1·0% (SD 1·0; 11 mmol/mol SD 11) in the intervention group, and 0·3% (SD 0·9; 3·3 mmol/mol 9·9) in the control group (p<0·0001). The frequency of hypoglycaemic events per month was similar between the groups (0·29 events per month SD 0·48 in the intervention group vs 0·29 SD 1·12 in the control group; p=0·96).
The combination of automated insulin titration guidance with support from health-care professionals offers superior glycaemic control compared with support from health-care professionals alone. Such a solution facilitated safe and effective insulin titration in a large group of patients with type 2 diabetes, and now needs to be evaluated across large health-care systems to confirm these findings and study cost-effectiveness.
US National Institutes of Health, National Institute of Digestive and Kidney Diseases.
Use of innovative technologies such as continuous glucose monitoring (CGM) and insulin delivery systems have been shown to be safe and effective in helping patients with diabetes achieve ...significantly improved glycemic outcomes compared to their previous therapies. However, these technologies are underutilized in many primary care practices. This narrative review discusses some of the clinical and economic benefits of tubeless insulin delivery devices and discusses how this technology can overcome the main obstacles inherent to use of conventional insulin delivery devices.
Advances in insulin delivery technologies have led to the development of tubeless "patch" systems; however, these devices still involve a level of complexity. We surveyed individuals with type 1 or ...type 2 diabetes to explore their attitudes and satisfaction after using the CeQur Simplicity insulin patch (SIP) for 2 months. Transition to the SIP yielded significant increases in respondents' overall treatment satisfaction, less diabetes burden, and improvements in psychological well-being compared with respondents' prior insulin delivery method.
The Tandem Control-IQ (CIQ) system has demonstrated significant glycemic improvements in large randomized controlled and real-world trials. Use of this system is lower in people with type 1 diabetes ...(T1D) government-sponsored insurance and those with type 2 diabetes (T2D). This analysis aimed to evaluate the performance of CIQ in these groups.
A retrospective analysis of CIQ users was performed. Users age ≥6 years with a t:slim X2 Pump and >30 days of continuous glucose monitoring (CGM) data pre-CIQ and >30 days post-CIQ technology initiation were included.
A total of 4243 Medicare and 1332 Medicaid CIQ users were analyzed among whom 5075 had T1D and 500 had T2D. After starting CIQ, the Medicare beneficiaries group saw significant improvement in time in target range 70-180 mg/dL (TIR; 64% vs. 74%;
< 0.0001), glucose management index (GMI; 7.3% vs. 7.0%;
< 0.0001), and the percentage of users meeting American Diabetes Association (ADA) CGM Glucometrics Guidelines (12.8% vs. 26.3%;
< 0.0001). The Medicaid group also saw significant improvement in TIR (46% vs. 60%;
< 0.0001), GMI (7.9% vs. 7.5%;
< 0.0001), and percentage meeting ADA guidelines (5.7% vs. 13.4%;
< 0.0001). Patients with T2D and either insurance saw significant glycemic improvements.
The CIQ system was effective in the Medicare and Medicaid groups in improving glycemic control. The T2D subgroup also demonstrated improved glycemic control with CIQ use. Glucometrics achieved in this analysis are comparable with those seen in previous randomized controlled clinical trials with the CIQ system.
Numerous studies have demonstrated the clinical value of continuous glucose monitoring (CGM) in type 1 diabetes and type 2 diabetes populations. However, the eligibility criteria for CGM coverage ...required by the Centers for Medicare & Medicaid Services (CMS) ignore conclusive evidence that supports CGM use in various diabetes populations that are currently deemed ineligible. This article discusses the limitations and inconsistencies of the CMS eligibility criteria relative to current scientific evidence and proposes workable solutions to address this issue and improve the safety and care of all individuals with diabetes.
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