Optimising self-management in youth with type 1 diabetes to improve short-term glycaemic control: OPTIMISE Study

Not Applicable

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620001017910
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Study Completion: 2022-09-07
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in percentage of time in range (3.9-10.0 mmol/mol) as measured by an interstitial continuous glucose monitoring sensor in the 14 days prior to the baseline and final study visits. [Baseline, 14-days, 28-days post-commencement of intervention. ]