Applying the use of shared medical appointments (SMAs) to improve continuous glucose monitor (CGM) use, glycemic control, and quality of life in marginalized youth with type 1 diabetes: Study protocol for a pilot prospective cohort study.
Applying the use of shared medical appointments (SMAs) to improve continuous glucose monitor (CGM) use, glycemic control, and quality of life in marginalized youth with type 1 diabetes: Study protocol for a pilot prospective cohort study.
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DOI：
10.1016/j.conctc.2023.101067
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发表时间：
2023-04
影响因子：
1.5
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在患有1型糖尿病(T1D)的青年中，连续血糖监测仪(CGM)与改善血糖控制和糖尿病相关的生活质量有关，但在来自低收入家庭和种族/少数民族的青年中使用率最低。共享医疗预约(SMA)已被证明可以改善患有T1D的青少年的血糖控制和减少糖尿病痛苦，但一直缺乏对边缘化青年的关注。这项前瞻性队列试点研究将评估SMA干预的可行性和可接受性，以及对糖化血红蛋白(HbA1C)升高的边缘化青年CGM摄取和持续使用、血糖控制和糖尿病痛苦的影响。这项试点研究将招募20名8-12岁的患有T1D的公共保险青年，他们认为自己是非西班牙裔黑人或拉丁裔，并且在过去一年中至少有一项HbA1C值超过8%；以及他们的主要照顾者。该试验将采用登记访问，SMA在12个月的研究期内每3个月访问一次，并进行6个月的跟踪观察期。可行性措施包括成功招募符合条件的青年参加的比例、发起CGM的比例、参加SMA的比例以及通过学习完成留住学生的比例。可接受性将使用满意度调查进行评估。血糖控制的变化将使用CGM指标和A1c从基线到完成为期12个月的SMA干预，以及在SMA干预完成后3个月和6个月进行评估。为边缘化青年实施SMAS有可能通过优化患有T1D的最脆弱青年的临床和心理社会结果来解决糖尿病差距问题。试用注册：https://clinicaltrials.gov/ct2/show/NCT05431686.
Continuous glucose monitors (CGMs) have been associated with improved glycemic control and diabetes-related quality of life in youth with type 1 diabetes (T1D), however use is lowest among youth from low-income households and racial/ethnic minorities. Shared medical appointments (SMAs) have been shown to improve glycemic control and reduce diabetes distress in adolescents with T1D, but a focus on marginalized youth has been lacking. This prospective cohort pilot study will assess feasibility and acceptability of the SMA intervention and impact on CGM uptake and sustained use, glycemic control, and diabetes distress in marginalized youth with elevated hemoglobin A1c (HbA1C). The pilot study will recruit 20 publicly insured youth with T1D aged 8–12 years who identify as non-Hispanic Black or Latinx and have had at least one HbA1C value > 8% in the past year and their primary caretaker. The trial will employ an enrollment visit, SMA visits every 3 months over a 12-month study period, and a 6-month follow-up observational period. Feasibility measures include proportion of eligible youth successfully recruited for participation, proportion initiating CGM, SMA attendance, and retention through study completion. Acceptability will be assessed using satisfaction surveys. Changes in glycemic control will be assessed using CGM metrics and A1c from baseline to completion of the 12-month SMA intervention, as well as 3 and 6-months after completion of the SMA intervention. Implementing SMAs for marginalized youth has the potential to address diabetes disparities by optimizing clinical and psychosocial outcomes for the most vulnerable youth living with T1D. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05431686.