NCT05140564

Safe Management of People With Type 1 Diabetes and EAting Disorders studY

Safe Management of People With Type 1 Diabetes and EAting Disorders studY - Phase II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is currently no effective intervention for type 1 diabetes and eating disorders. The main objective of STEADY Stage 2 is to test the feasibility of the newly developed STEADY intervention. STEADY was co-designed by using Experience Based Co-Design methodology and other qualitative methods (focus groups, interviews). These findings informed the development of a T1DM cognitive behaviour therapy (CBT) manual. The intervention will now be tested in a feasibility Randomised Controlled Trial (RCT) in adults with type 1 diabetes and eating disorders and compared with usual clinical care. If STEADY is feasible, this may provide an effective intervention for this population. This study will take place at King's College London. Participants will remain in the study for 6 months, with a 12-month extended observation period. The study is expected to end in February 2023.

Conditions

• Diabetes Mellitus, Type 1
• Eating Disorders

Interventions

Type	Name	Description
BEHAVIORAL	STEADY intervention	STEADY is a novel Cognitive Behavioural Therapy (CBT) based intervention for eating disorders in type 1 diabetes.

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2021-12-01
• Last updated: 2024-03-05

Locations

1 site across 1 country: United Kingdom