ResearchPad - diabetes-technology-and-advances-in-clinical-trials Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[OR30-01 Real-World Minimed™ 670G System Use and Glycemic Outcomes of Pediatric and Adult Individuals Living with Type 1 Diabetes (T1D) in the United States]]> Introduction: The MiniMed™ 670G system was FDA-approved in 2016 for adults and adolescents ≥14yrs, and in 2018 for children ages 7-13yrs with T1D. Since then, use of the system has grown to over 180,000 people in the U.S. The glycemic control benefits of real-world MiniMed™ 670G system Auto Mode use in the U.S. were assessed. Methods: System data (aggregated five-minute instances of sensor glucose [SG]) uploaded from March 2017 to July 2019 by individuals (N=118,737) with T1D and ≥7yrs of age who enabled Auto Mode were analyzed to determine the mean % of overall time spent <54mg/dL/<70mg/dL (TBR); between 70-180mg/dL (TIR); and >180mg/dL/>250mg/dL (TAR). The impact of Auto Mode was further assessed in a sub-group of individuals (N=51,254) with, at least, 7 days of SG data for both Auto Mode turned ON and turned OFF. The % of TIR, TBR and TAR, and the associated glucose management indicator (GMI) were evaluated for the overall OFF (2,524,570 days) and ON (6,308,806 days) periods, and across different age groups. Results: System data TIR was 71.3%; TBR was 0.4% and 1.9%, respectively; and TAR was 26.8% and 6.2%, respectively. User-wise data of Auto Mode OFF versus ON showed a mean of 70.3% of the time spent in Auto Mode, that TIR increased from 60.9% to 69.9%; and that both TBR and TAR decreased. For those 7-13yrs (N=1,417), TIR increased from 48.7% to 61.5%; TBR increased from 0.5% to 0.6% and from 2.0% to 2.2%, respectively; and TAR decreased from 49.3% to 36.3% and from 20.5% to 13.0%, respectively. For those 14-21yrs (N=4,194), TIR increased from 51.0% to 61.5%; TBR decreased from 0.7% to 0.6% and from 2.3% to 2.0%, respectively; and TAR decreased from 46.7% to 36.5% and from 18.5% to 12.5%, respectively. For those ≥22yrs (N=45,643), TIR increased from 62.2% to 70.9%; TBR decreased from 0.7% to 0.5% and from 2.6% to 1.9%, respectively; and TAR decreased from 35.2% to 27.3% and from 9.9% to 6.3%, respectively. The mean GMI decreased by 0.23% (overall), 0.48% (7-13yrs), 0.35% (14-21yrs), and 0.22% (22yrs), respectively, with Auto Mode ON versus OFF. Discussion: In over 6 million days of real-world MiniMed™ 670G system Auto Mode use in the U.S., TIR of a large pediatric and adult population with T1D improved by 9% compared to when Auto Mode was OFF, which was comparable to or exceeded the TIR observed in the smaller pivotal trials. These results further support outcomes of the pivotal trials and increased glycemic control with system use.

<![CDATA[OR30-03 Racial Differences in Technology Use Among Type 1 Diabetes in a Safety-Net Hospital]]> Objective: There is limited data regarding the use of diabetes technology such as continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII) among patients with type 1 diabetes (T1D) in a minority serving and safety-net hospital. We examined racial differences in the use of CGM and CSII in this setting.

Methods: A retrospective review of 227 patients ≥ 18 years of age with T1D seen in the Endocrinology clinic at a safety-net hospital from October 2016 and September 2017 was completed. Statistical analysis assessed the likelihood of diabetes technology use among different races.

Results: The mean age was 39, 59% male, mean duration of diabetes was 21 years, 30% overweight, 22% obesity, 80% English speaking, and 50% had government insurance. In terms of the distribution of race/ethnicity, 43% were Caucasian, 25% African American (AA), 15% Hispanic, 15% defined as other, and 2% Asian. Mean HbA1c ± standard deviation (SD) of any technology (either CGM or CSII or both) and non-technology users were 8.27 ± 1.58 and 9.49 ± 2.04, respectively. Patients who had government health insurance were found to have lower odds of using technology (odds ratio [OR], 0.43; 95% confidential interval [CI], 0.25 - 0.74) compared to patients who had private health insurance. Overall, 26% of the patients used CSII with 43% of this population Caucasian, 10.5% AA and 14.2% Hispanic. The overall CGM use was 30% with 47% of users Caucasian, 14% AA and 22% Hispanic. In a multivariable logistic regression model that adjusted for insurance and language, AA or other were found to have statistically significant lower odds of using technology (AA OR 0.25 [95% CI 0.11 - 0.53] and other OR 0.33 [95% CI 0.12 - 0.89]) compared to the Caucasian group.

Conclusion: Our study showed that the use of technology in the Caucasian group was statistically significantly higher than in the non-Caucasian groups except for the Asian group. After adjusting for insurance and language, AA and other demonstrated statistically lower rates of technology use. Racial differences in diabetes technology use were observed in our study as well as the association between technology use and lowered HbA1c. Given diabetes technology is a useful tool in reducing HbA1c and hypoglycemia, the barriers to accessing diabetes technology in non-Caucasian individuals should be addressed to decrease health disparities.

<![CDATA[OR30-07 Mixed Meal Tolerance Test (MMTT) Results from Revita-2, the First Randomized, Sham-Controlled, Double-Blind, Prospective, Multicenter Study of Duodenal Mucosal Resurfacing (DMR) Safety and Efficacy in Patients with Sub-Optimally Controlled Type 2 Diabetes (T2D)]]> <![CDATA[OR30-06 Assessment of Dulaglutide Safety in Older Patient Populations in Rewind]]>


Dulaglutide (DU) was superior to placebo (PL) in reducing the incidence of Major Adverse Cardiovascular Events in the Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND Study) broad patient population. The safety of DU treatment is also of interest to health care providers who treat an older patient population (≥65 years of age).

The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia. One of the key secondary objectives was first occurrence of severe hypoglycemia.

Patients were grouped into two age groups: ≥65 and <65 years. Time-to-event for the composite safety endpoint as well as individual variables were analyzed using Cox proportional hazards regression. Hazard ratios (HRs) and 95% confidence intervals (CIs) for between group treatment differences were also calculated.

Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 years. The incidence of the composite safety outcome for patients aged ≥65 years was 399 of 2619 (15.2%) for DU-treated patients and 425 of 2,637 (16.1%) for PL-treated patients. The incidence of the composite safety outcome for those aged <65 years was 188 of 2,330 (8.1%) for DU-treated patients and 224 of 2,315 (9.7%) for PL-treated patients. Between group treatment differences (HR [95% CI]) were 0.94 (0.82, 1.08) for patients ≥65 years of age and 0.82 (0.68, 1.00) for patients <65 years of age; interaction p-value = 0.277. The incidence of the secondary outcome of first occurrence of severe hypoglycemia for patients aged ≥65 years was 46 of 2619 (1.8%) for DU-treated patients and 49 of 2,637 (1.9%) for PL-treated patients. The incidence of this outcome for patients <65 years was 18 of 2,330 (0.8%) for DU-treated patients and 25 of 2,315 (1.1%) for PL-treated patients. Between group treatment differences (HR [95% CI]) were 0.95 (0.63, 1.42) for patients ≥65 years of age and 0.71 (0.39, 1.31) for patients <65 years of age; interaction p-value = 0.443. The safety profile of DU was reviewed based upon the results of subgroup analysis of treatment emergent adverse events and serious adverse events by preferred terms for comparing PL and DU for age subgroups (≥65 years of age versus <65 years). None of the results indicated that DU has a different safety profile across the age subgroups evaluated in this post-hoc analysis.

Treatment with DU demonstrated similar safety in REWIND patients aged ≥65 years and those aged <65 years. Dulaglutide can be considered a safe and effective treatment option for use in older adults.

<![CDATA[OR30-04 Autonomous Drone Delivery of Insulin]]> <![CDATA[OR30-02 Efficacy and Safety Comparison Between U100 Regular Human Insulin and U100 Rapid Acting Insulin When Delivered by a 24 Hour Wearable Insulin Delivery Device in Type 2 Diabetes]]>