Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial.

Capillary hemoglobin A1c (HbA1c) collection has grown in importance due to its convenience during situations such as the coronavirus disease 2019 (COVID-19) pandemic and virtual visits. The viability of capillary blood samples as an accurate alternative to venous samples has previously only been assessed in smaller sample sizes. In this brief report, 773 paired capillary and venous samples taken from 258 study participants in the Insulin-Only Bionic Pancreas Trial were analyzed at the University of Minnesota Advanced Research and Diagnostic Laboratory and assessed for HbA1c value congruency. Results showed that 97.7% of the capillary samples were within 5% of their respective venous measurement, and R2 between the two HbA1c sources was 0.95. These results are consistent with previous studies that also reported high concordance between capillary and venous HbA1c values using the same laboratory method, providing further evidence that capillary HbA1c measurements are an accurate alternative to venous measurements. Clinical Trial Registration number: NCT04200313.

Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.

BACKGROUND: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. METHODS: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. RESULTS: A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).

Accuracy of Three Commercial Home-Use Hemoglobin A1c Tests.

Background: The COVID-19 pandemic and the rapid expansion of telemedicine have increased the need for accurate and reliable capillary hemoglobin A1c (HbA1c) testing. Nevertheless, validation studies of commercially available products suitable for home use have been in short supply. Methods: Three commercial home-use capillary blood sample HbA1c tests (Home Access, CoreMedica, and A1cNow+) were evaluated in 219 participants with type 1 or type 2 diabetes (4-80 years years of age, HbA1c 5.1%-13.4% [32-123 mmol/mol]) at four clinical sites. Comparisons were made between HbA1c measurements from the commercial tests and paired venous samples for which HbA1c was measured at two central reference laboratories. The primary outcome was percentage of commercial HbA1c values within 5% of the corresponding reference values. Results: HbA1c values were within 5% (relative difference) of paired reference values for 82% of Home Access samples, 29% of CoreMedica samples, and 46% of A1cNow+ samples. Absolute differences were within 0.3% of the reference value for 75% of Home Access samples, 28% of CoreMedica samples, and 44% of A1cNow+ samples and exceeded 0.5% for 8%, 55%, and 37%, respectively. Conclusions: None of the commercial home-use HbA1c tests produced the National Glycohemoglobin Standardization Program goal of ≥90% measurements within 5% of a DCCT venous reference. However, the Home Access product performed substantially better than the CoreMedica or A1cNow+ products. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home-based HbA1c assessment represents an urgent need for the diabetes community.

TELEHEALTH USER EXPERIENCE AND ENVIRONMENTAL IMPACT FOR TELEPHONE AND VIDEO VISITS FOR GASTROESOPHAGEAL REFLUX DISEASE

Introduction: Sars-CoV-2 virus pandemic of 2019 necessitated a transition to telehealth for many healthcare encounters. The telehealth user experience and any potential environmental impact of this transition to e-Visits for gastrointestinal diseases is hitherto unstudied. Methods: We conducted a retrospective cohort study of patients who underwent telehealth encounters (telephone visits and video visits) with the outpatient gastroenterology clinics at West Virginia University, Morgantown. Patients were reached by telephone and were asked to provide information to fill in pre-designed survey questionnaires that incorporated a validated telehealth usability questionnaire. The Telehealth usability questionnaire (TUQ) incorporated Likert scales (1-7) to rate usability questions. Variables were also collected with chart review by two study authors. Distance of patients’ residence from our clinic was calculated using demographic data on EPIC. Environmental protection agency (EPA) calculators were utilized to calculate greenhouse emissions that were prevented due to televisits in lieu of in person visits. Results: A total of 81 video visits and 89 telephone visits were performed for GERD in the study period of March 2020-March 2021. 111 patients were able to be enrolled in the study and filled in the questionnaires, revealing a response rate of 65.29%. Mean age was higher in the telephone visit cohort (43.45 +/- 14.32 vs 52.34 +/- 17.46, p: 0.04) and most participants were female (76.58%). Overall user satisfaction was high (mean scores for all usability variates >5). Comparative analysis of the telephone and video visits revealed significantly higher mean ratings for usefulness and user comfort questions in the patients who had video encounters compared to those with telephone encounters, as shown in Table 2. A total of 7.02 metric tons of greenhouse gas emissions were prevented due to non-usage of the 391.5 gallons of gasoline needed to transport these patients to and from the facility from their residence. Conclusion Telehealth visits for GERD were rated highly in terms of usefulness, satisfaction, and user comfort/usability by patients. Video visits received higher mean ratings for usefulness and user comfort. Tele-visits for GERD are therefore well received by patients and in addition can contribute to notable reductions in unnecessary greenhouse emissions. (Table Presented)

Effectiveness of Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes Treated with Basal Insulin.

Objective: To evaluate the effectiveness and safety of real-time continuous glucose monitoring (CGM) in adults 65 years old and older with type 2 diabetes (T2D) using basal without bolus insulin. Research Design and Methods: Using data from the MOBILE randomized trial comparing CGM versus blood glucose meter (BGM) monitoring for T2D treated with basal insulin, the treatment effect in participants ≥65 years (range: 65-79 years, N = 42) was compared with the treatment effect in participants <65 years (range: 33-64 years, N = 133). Results: For participants ≥65 years old, mean change in hemoglobin A1c (HbA1c) was -1.08% in the CGM group and -0.38% in the BGM group (adjusted mean difference = -0.65% [95% confidence interval (CI) -1.49 to 0.19]). In contrast, the adjusted mean difference in HbA1c between treatment groups was -0.35% [95% CI -0.77 to 0.07] in the <65 years age group. For time in range 70-180 mg/dL (TIR), mean adjusted treatment group difference was 19% (95% CI 4 to 35, P = 0.01) in ≥65 years old participants and 12% (95% CI 4 to 19, P = 0.003) in those <65 years old. Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups. Conclusions: In this study of adults with T2D treated with basal insulin without bolus insulin, participants ≥65 years old using CGM had a greater increase in TIR and a reduction in hyperglycemia than those using BGM and the benefit appeared to be at least as great as that observed in younger adults.

An Evaluation of Two Capillary Sample Collection Kits for Laboratory Measurement of HbA1c.

Background: The COVID-19 pandemic has impacted the conduct of clinic visits. We conducted a study to evaluate two academic laboratories' fingerstick capillary blood collection kits suitable for home use for laboratory measurement of HbA1c. Methods: Four clinical sites recruited 240 participants (aged 4-80 years, HbA1c 5.1%-13.5%). Capillary blood samples were obtained by the participant or parent using collection kits from two laboratories (University of Minnesota Advanced Research and Diagnostic Laboratory (ARDL) and Children's Mercy Hospital Laboratory (CMH)) and mailed under varying shipping conditions by United States Postal Service to the laboratories. Comparisons were made between HbA1c measurements from capillary samples and contemporaneously obtained venous samples. The primary outcome was percentage of capillary HbA1c values within 5% of the corresponding venous values. Results: HbA1c values were within 5% of venous values for 96% of ARDL kit specimens shipped with a cold pack and 98% without a cold pack and 99% and 99%, respectively, for the CMH kits. R2 values were 0.98, 0.99, 0.99, and 0.99, respectively. Results appeared similar across HbA1c levels and for pediatric and adult participants. Usability survey scores were high. Conclusions: Capillary blood collection kits, suitable for home use, from two academic laboratories, were demonstrated to be easy to use and provided results that are comparable with those obtained from venous specimens. Based on these results, there is strong evidence that HbA1c measurements from capillary specimens obtained with these specific kits can be used interchangeably with HbA1c measurements from venous specimens for clinical research and clinical care.