Objective: Clinical trial data demonstrates improved glycemic control with hybrid close loop (HCL) insulin delivery systems, yet limited real-world data exists. Data from the inaugural cohort of patients initiating a HCL system (Medtronic MiniMed™ 670G, Medtronic Canada, Brampton, ON) at a university medical center was used to examine real-world utilization and glycemic control following a standardized implementation process. Methods: Data from 34 adult patients with type 1 diabetes were obtained from pump downloads at 4 time points: (1) previous insulin pump, (2) HCL in manual-mode, (3) 2 weeks after HCL auto-mode transition, and (4) 6 to 12 weeks after initiation of HCL. In-person training by certified diabetes educators was performed across 3 sessions with phone and electronic messaging following auto-mode start. Results: Mean self-monitored blood glucose (SMBG) per day increased from 5.15 baseline to 6.49 at 6 to 12 weeks (P<.05) with 3.26 sensor calibrations per day. Time-in-auto-mode was 79.3% at 2 weeks and 72.3% at final follow-up, with 82% of patients spending >50% of time in auto-mode. There were 8.2 auto-mode exits over the final 14-day download. Time-in-target was 67.3% in manual-mode, 73.4% at 2 weeks (P = .09), and 71.7% by 6 to 12 weeks (P = .06). Hemoglobin A1c (HbA1c) decreased by 0.51% (P = .02), while total daily dose and % basal did not change. Patients with HbA1c <7.0% (53 mmol/mol) at baseline spent more time-in-target than those with HbA1c ≥7.0% (53 mmol/mol; 78.0% versus 67.5%) despite spending less time-in-auto-mode (66.5% versus 74.8%). Conclusion: These data illustrate real-world implementation of HCL technology using a structured education program within a major medical center. Overall benefit may vary based on baseline characteristics such as HbA1c.
Background/ Objective: Complications can ensue from uncontrolled type 1 diabetes, resulting in compromised quality and duration of life, and increased health care costs. The provision of insulin is achieved by multiple daily injections (MDI) or by insulin pump through continuous subcutaneous insulin infusion (CSII). The primary objective was to determine the difference between hemoglobin A 1c (HbA 1c) before and after the switch from MDI to CSII therapy. Methods: In this retrospective medical record review, paired t-tests were used for all of the pre-post comparisons. To determine whether external factors were related to a successful reduction in HbA 1c after pump initiation, the pre-post HbA 1c difference was used as the outcome in a linear regression model, and potential patient characteristic covariates were evaluated univariately for their predictive ability: age, gender, duration of diabetes, age at diagnosis, average insulin pre-pump units (absolute and per kg body weight), weight, insulin and pump types, and the presence of various complications. Of the 107 subjects initially identified, 42 subjects met inclusion criteria. Results: The average HbA 1c of participants decreased by 0.55% from pre-pump values (P = 0.0001), the average daily insulin dose per kilogram of body weight decreased by 0.061 iii U/kg, (P = 0.0029), and weight decreased by 0.07 kg. (P=0.86). None of the continuous or categorical variables were found to be statistically significant at predicting a pre-to post-reduction in HbA 1c levels. Conclusions: This study suggests that all study participants, regardless of patient characteristics, benefited from the transition from MDI to CSII therapy. Gregory Young for his interest and commitment in helping to develop the statistics for this study and Dr. Christopher Taylor for his last minute assistance with formatting. I would also like to thank Dr. Marcia Nahikian-Nelms for her careful reading to improve the final manuscript and my mom for her assistance with editing. Finally, I would like to thank my family for their unwavering love and support throughout the last three years. Their words of encouragement and confidence, as well as their unending ability to provide a voice of reason and a listening ear, were greatly appreciated.
Objective: As diabetes technologies increase in prevalence and complexity, flexible models of care are needed to provide ongoing support. The objective of this study is to determine whether a streamlined Diabetes Device Clinic (DDC) model is associated with improvement in glycemic control and education utilization among insulin pump users. Research Design and Methods: The DDC was available for patients in need of focused device-related education; all patients had previously received comprehensive education and insulin pump training. The DDC consists of an abbreviated visit with a certified diabetes educator (CDE, 40 minutes) followed by a hand-off and visit with the endocrinologist (20 minutes). Participants were compared to insulin pump users who received traditional care. Pre- and post-HbA1c values were obtained within 6 months prior to and 6 months after the DDC visit. The two most recent HbA1c values at least 3 months apart were obtained for non-device clinic patients. Results: A total of 437 patients were identified, 79 of whom attended the DDC. Of the non-attendees (n=358), 48.7% were referred to the CDE and 39% completed an education visit. Among patients with a baseline HbA1c >8.0%, those who attended the DDC witnessed a significant reduction in HbA1c (-0.52% +/- 0.71, p=0.002) whereas non-attendees saw no such improvement (-0.14% +/- 1.29, p=0.29). For patients with a baseline HbA1c <8.0%, there was a slight increase in HbA1c in DDC attendees and no change in non-attendees (0.20% +/- 0.66, p=0.028, vs. 0.04% +/- 0.54, p=0.24 respectively). Multivariable analysis confirmed a significant interaction between baseline HbA1c and DDC. Results were similar in patients receiving traditional education. Conclusions: These data illustrate that the streamlined DDC model of care may improve glycemic control and education utilization among established insulin pump patients. Additional study is needed to address ongoing education needs. Disclosure C.K. Park: None. J.G. Zappe: None. E. Snyder: None. K.M. Dungan: Advisory Panel; Self; Eli Lilly and Company, Elsevier, Sanofi-Aventis. Research Support; Self; Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk Inc., Sanofi-Aventis, Viacyte. Other Relationship; Self; DKBmed, UpToDate.
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