Grundman Jody B, Majidi Shideh, Perkins Amanda, Streisand Randi, Monaghan Maureen, Marks Brynn E
Division of Endocrinology, Children's National Hospital, 111 Michigan Ave NW, Washington, DC, USA.
George Washington University School of Medicine and Health Sciences, 2300 I St NW, Washington, DC, 20052, USA.
Contemp Clin Trials Commun. 2023 Jan 16;32:101067. doi: 10.1016/j.conctc.2023.101067. eCollection 2023 Apr.
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.
连续血糖监测仪（CGM）与改善1型糖尿病（T1D）青少年的血糖控制及糖尿病相关生活质量相关，但低收入家庭以及少数族裔青少年对其使用率最低。共享医疗预约（SMA）已被证明可改善T1D青少年的血糖控制并减轻糖尿病困扰，但一直缺乏对边缘化青少年的关注。这项前瞻性队列试点研究将评估SMA干预措施的可行性和可接受性，以及对边缘化且糖化血红蛋白（HbA1C）升高的青少年的CGM采用率和持续使用率、血糖控制及糖尿病困扰的影响。
该试点研究将招募20名年龄在8至12岁、患有T1D的公共保险青少年，他们自我认定为非西班牙裔黑人或拉丁裔，且在过去一年中至少有一次HbA1C值>8%，并招募他们的主要照顾者。该试验将包括一次入组访视、在为期12个月的研究期间每3个月进行一次SMA访视，以及为期6个月的随访观察期。可行性指标包括成功招募参与研究的符合条件青少年的比例、开始使用CGM的比例、SMA的出勤率以及直至研究结束的保留率。将使用满意度调查来评估可接受性。血糖控制的变化将通过CGM指标以及从基线到12个月SMA干预完成时、SMA干预完成后3个月和6个月的HbA1C来评估。
为边缘化青少年实施SMA有可能通过优化最易患T1D的青少年的临床和心理社会结局来解决糖尿病差异问题。试验注册：https://clinicaltrials.gov/ct2/show/NCT05431686 。
