Background: Non-Hispanic Black (NHB) youth with T1D are more likely to have suboptimal glycemic control and less likely to use HCL systems or to be included in clinical trials. We evaluated changes in glycemic control with use of Tandem t:slim X2 insulin pump with Control-IQ technology in this historically underrepresented population in T1D research. Methods: This prospective non-randomized pilot study enrolled 15 pump naïve, publicly insured, NHB youth (Mage 14.6 ± 3.7) with T1D and A1c ≥10% in a 6 month trial of HCL use. Changes in A1c (n=13) and CGM-measured glycemia at baseline versus the final 90 days of the study for those with <70% wear time (n=12) were assessed using paired t-tests and Wilcoxon signed rank tests. Results: Thirteen participants (87%) completed the study; one was removed after 2 episodes of diabetic ketoacidosis (DKA) and the other for protocol non-adherence. A1c decreased from 11.7±1.3% to 9.6±1.6% (p=0.001). Average sensor glucose decreased from 281±53 to 225±30 mg/dL and time in range (TIR) increased by 4.5±8.5 hours/day from 18.5±15.0% to 37.1±10.3% (p=0.007). Time above range (TAR) <180 mg/dL decreased by 4.6±4.5 hours/day from 81.3±15.4% to 62.0±10.3% (p=0.007). There were no changes in time below range <70 mg/dL (p=0.72). DKA did not increase (0.67 episodes/person-year pre-enrollment vs 0.58 episodes/person-year during study intervention). Conclusions: Tandem t:slim X2 insulin pump with Control-IQ technology use in NHB youth with suboptimal T1D control was associated with improvements in average glucose, TIR, and TAR. The theoretical risk for increased risk of DKA is frequently cited as a barrier to HCL use in this population, however there was no increase in rates of DKA during the study period. These glycemic improvements without increased risk emphasize the importance of supporting equitable access to diabetes technology among all people with T1D. Disclosure B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic. J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Meighan: Speaker's Bureau; Dexcom, Inc. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. R.Streisand: None. A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. Funding National Institutes of Health (K23DK129827); Tandem Diabetes Care, Inc. (TDC20210226); Dexcom, Inc.
Background: Prior HCL studies enrolling participants with well-controlled T1D and limited financial, racial-ethnic, and socioeconomic diversity have shown limited success in improving patient-reported outcomes (PROs). We evaluated changes in PROs among marginalized youth with T1D and their parents after 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology use. Methods: This non-randomized 6-month pilot study enrolled 15 publicly insured, non-Hispanic Black (NHB) youth with T1D and hemoglobin A1c (HbA1c) ≥10% (Mage 14.6 ± 3.7 yrs, MT1Dduration 8.5 ± 4.8 yrs, MA1c11.9±1.4%). Youth and parent PROs at baseline and 6-months were compared using paired t-tests. The following constructs were assessed using validated PROs: DRQL using T1D and Life (T1DAL), emotional distress using Problem Areas in Diabetes (PAID), positive expectancy of technology using INSPIRE, and self-management behaviors using Diabetes Management Questionnaire (DMQ). Results: Thirteen participants completed the study. HbA1c decreased from 11.7±1.3% to 9.6±1.6% over 6 months (p=0.001). TIDAL scores increased among parents and youth (p-T1DAL +7.1 to 70±13, p=0.01; y-T1DAL +8 to 69±12, p=0.03). PAID scores decreased among parents and youth (p-PAID -25 to 43±30, p=0.01; y-PAID -19.4 to 23±19, p=0.02). There were no changes in parent or child INSPIRE (p=0.23, p=0.88) or DMQ scores (p=0.44, p=0.16). Conclusions: Six months of Tandem t:slim X2 insulin pump with Control-IQ technology in marginalized youth with T1D improved HbA1c, DRQL, and diabetes-related distress among parents and youth despite no change in diabetes self-management behaviors or decrease in positive expectancy of HCL. Including diverse populations in T1D research and supporting equal access to HCL technology for all people with T1D may demonstrate psychosocial benefits with no additional burden for youth and their parents. Disclosure A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Meighan: Speaker's Bureau; Dexcom, Inc. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. R.Streisand: None. B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic. Funding Tandem Diabetes Care, Inc. (TDC20210226); National Institutes of Health (K23DK129827); Dexcom, Inc.
Introduction: Minority youth are underrepresented in diabetes technology trials. An ongoing pilot study is recruiting 20 publicly insured, insulin pump naive youth ages 8-12 with T1D who identify as NHB or Latinx with recent HbA1c >8% to participate in a study using SMAs to improve T1D self-management and sustained CGM use. We aimed to identify the most successful recruitment strategies. Methods: Potentially eligible youth are identified through weekly review of diabetes appointments. Families are then contacted in-person at a clinic visit, by phone, or text-message. We reviewed the number of in-person, phone, and text-message attempts for all eligible participants, as well as the number of youth who enrolled, refused, or who have not yet been successfully contacted. Results:79 youth were identified as potentially eligible. 56% (n=44, 16±13 contact attempts) have been successfully contacted; 18% (n=14, 6±4 contact attempts) enrolled. 64% (n=9/14) of enrolled and 18% (n=12/65) of non-enrolled were approached at a clinic visit, 14% (n=2/14) of enrolled and 40% (n=26/65) of non-enrolled via phone, and 50% (n=7/14) of enrolled and 46% (n=30/65) of non-enrolled via text-message (p<0.001). 38% (n=6/16) of those who scheduled an enrollment visit after being contacted by phone/text attended the visit versus 63% (n=10/16) contacted at a clinic visit (p<0.001). 38% (n=30, 10±9 contact attempts) refused to participate; 27% (n=9) did not want to travel to the study site, 17% (n=5) refused CGM, and 53% (n=16) declined research participation. 46% (n=35, 12±5 contact attempts) have not yet been successfully contacted. Conclusions: Historically marginalized youth enrolling in this SMA study required an average of 6 contact attempts for study participation. Purposeful in-person recruitment strategies, being mindful of the low rates of technology use among this community and mistrust in the healthcare system, is needed to promote diversity and inclusion in T1D research. Disclosure J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Majidi: None. A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. R.Streisand: None. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic. Funding American Diabetes Association (7-21-PDFHD-09 to J.G.)
Introduction: We evaluated potential factors influencing CGM uptake and sustained use to better understand the worsening disparities in CGM use among American youth with type 1 diabetes. Methods: This is a retrospective chart review of youth with type 1 diabetes less than 21 years old seen at a tertiary care center from 1/1/2021 to 11/5/2021. Most recent clinic note and prescriptions were used to determine CGM use (active, attrition, never) and whether CGM was accessed through pharmacy or durable medical equipment. Binary logistic regression was used to assess effects of age, sex, race/ethnicity, insulin regimen, health insurance, and CGM supplier on CGM uptake and sustained use. χ2 was used to assess the impact of language in Latinx youth. Results: Chart review identified 13youth (female 48.1%, NHW 43.7%, NHB 32.7%, Latinx 10.5%, publicly insured 52.1%) . Table 1 shows predictor variables associated with CGM use. NHW youth were more likely to have ever used CGM while CGM attrition was more common in NHB youth. Ever and active CGM use were less common in publicly insured youth and more common in pump users. CGM use was more common in Latinx English speakers than Spanish speakers (75.4% vs. 56.6%, p=0.03) . Conclusions: In an era of rapidly advancing technologies, efforts to support equity in diabetes technology use in publicly insured, minority, non-English speaking youth with type 1 diabetes may help to address disparities in health outcomes. Disclosure J. Grundman: Research Support; American Diabetes Association. M. Castro: None. A.E. Hoover: None. M. Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases. Research Support; American Diabetes Association. R. Streisand: None. A.G. Perkins: None. J.K. Reilly: None. A.M. Richardson: None. B. Goggin: None. B.E. Marks: Advisory Panel; JDRF. Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. Funding American Diabetes Association (7-21-PDFHD-09)
Background: AID systems improve glycemic control in youth with type 1 diabetes (T1D). There was a full market release of the OmniPod 5 (OP5) AID system in the United States on 8/1/2022 and it was FDA approved for ages ≥2 on 8/22/22. OP5 is available through pharmacy benefits and requires users to have a smartphone. We hypothesized that disparities exist in OP5 access. Methods: We assessed OP5 use at two pediatric diabetes centers among youth with T1D ages 2-21 who were using any version of an OmniPod (OP) insulin pump 3-months after the full market release. Differences in demographic characteristics of OP5 users compared to other OP pump users were assessed using Chi-squared and student’s independent two-sample t tests. Results: Of 1037 youth (mean age 12.8±4.4 years, 49.5% female, mean T1D duration 5.3±3.7 years), 510 (49.2%) were using OP5. Rates of OP5 use were higher among non-Hispanic White youth than among youth of all other racial/ethnic identities (53.2% vs 38.0%, p<0.0001). Youth using OP5 were more likely to be younger (12.3±4.0 years vs 13.2±4.7 years, p=0.0001) and to have a shorter T1D duration (4.9±3.5 vs 5.8±3.9 years, p=0.0002). There was a trend towards lower rates of uptake among publicly versus privately insured youth (43.1% vs 50.7%, p=0.054). There was no difference in OP5 use by sex (48.2% female vs 51.8% males, p=0.43). Conclusions: Minority youth were less likely to access the OP5 AID system 3-months after full-market release. Given the glycemic improvements associated with AID systems, it is important to promote equitable access to the latest diabetes technologies. Improving insurance coverage of technologies and supporting AID access without the need for a smartphone may support these goals. Disclosure B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic. S.Meighan: Speaker's Bureau; Dexcom, Inc. E.A.Brown: None. A.Zehra: None. R.Suresh: None. J.L.Douvas: None. R.M.Wolf: Research Support; Dexcom, Inc., Boehringer Ingelheim Inc. Funding National Institutes of Health (K23DK129827)
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.