Developing a multicomponent intervention targeting short-term glycaemic control in youth with type 1 diabetes: An optimisation trial of glucose monitoring, sleep hygiene, snacking education and values-guided self-management interventions

niversity of Otago0 个研究点目标入组 20 人开始时间: 2020年10月7日最近更新: 2023年7月25日

适应症

试验速览

暂无简介。

•This study will enrol youth:
•with a type 1 diabetes diagnosis of at least 12 months
•have a mean HbA1c of at least 58 mmol/mol (above clinical recommendations for HbA1c) in the 6 months prior to enrolment
•self-report time in bed (time between lights out and waking in the morning) of no more than 10 hours a night (ensuring any sleep extension does not place them in the not recommended” category for sleep duration (greater than 11 hrs);
•be willing to wear an ActiGraph (a wrist-worn device for measuring activity, similar to a FitBit) continuously for 7 days and 8 nights during the first and final weeks of the study period;
•be willing to discuss barriers to self-management with a member of research staff who is not involved with their diabetes care; and
•be willing to wear an interstitial glucose sensor for 6 weeks.

•significant comorbidities that would interfere with study participation (e.g., uncontrolled diabetes complications, uncontrolled psychiatric conditions [PHQ-9 score is greater than or equal to 20 (severely depressed)], diagnosed sleep disorders, diagnosed and currently active eating disorder);
•current user of continuous glucose monitoring technology (other than intermittent hospital/ clinical use in the previous 3 months; current FreeStyle Libre ‘flash’ glucose monitoring use is not an exclusion criterion);
•chronic use of sleep medication; or
•shift worker (works or has plans to work at least 3 hours between midnight and 5am

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