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

Sponsor

King's College London (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05140564

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Eating Disorders	Behavioral: STEADY intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 18, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STEADY intervention group	Behavioral: STEADY intervention STEADY is a novel Cognitive Behavioural Therapy (CBT) based intervention for eating disorders in type 1 diabetes.
No Intervention: Treatment as usual group (control)

Arm

Intervention/Treatment

Experimental: STEADY intervention group

Behavioral: STEADY intervention

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

No Intervention: Treatment as usual group (control)

Outcome Measures

Primary Outcome Measures

HbA1c [6 months]
HbA1c measured in mmol/mol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (≥18 years);
Diagnosis of type 1 diabetes mellitus for at least 6 months;
Current disordered eating: defined as fear of insulin as weight gaining, avoidance/ restriction of insulin to control weight, food restriction, binge eating, any additional disordered eating behaviour as described by the 5th revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), or 11th Revision of the International Classification of Diseases (ICD-11); AND/OR score of 15 on EDE-QS, AND/OR a score of 20 on the DEPS-R.
Prepared to take part in a cognitive-behavioural therapy approach behaviour change strategy plus diabetes education intervention (with up to 12 sessions) with a varying proportion of face-to-face and virtual delivery mode;
Prepared to take part in the control group - treatment as usual (TAU)
Prepared to attend physical and mental health check-up at baseline and at the end of the intervention (control arm and intervention arm) face-to-face;
Currently under the care of a diabetes specialist team (as this study does not replace usual diabetes care);
Confirms availability to attend all sessions as part of the intervention (with the option of rescheduling sessions when necessary. Therapy sessions may be in person or via videoconference);
Investigator has confidence that the participant is able to fulfill all of the trial protocol requirements;
Participant has capacity to consent to the study. This is assessed by ability to explain information about their involvement in the study.

Exclusion Criteria:

HbA1c >15%/ 140.4 mmol/mol;
More than 2 admissions for DKA in the past 12 months;
More than 2 SH episodes (defined as needing 3rd party assistance) in the past 12 months due to insulin omission (not if triggered by infection or canula failure);
Severe mental illness, including severe depression with suicidal ideation, psychosis, emotionally unstable personality disorder requiring more intensive psychiatric treatment, substance problem use and dependence. (Potential participants with more severe mental illness are unlikely to benefit from a CBT based approach, therefore will be excluded to not delay their treatment. Investigators will use their clinical judgement, in agreement with the trial team. Mental health assessment by a psychiatrist is part of the baseline visit.);
Body mass index below 15kg/m2 or above 40kg/m2;
Significant cognitive impairment, e.g. dementia, learning disability;
Unable to speak/hear/understand/read/write in English;
Unable to give written informed consent;
Pregnant or planning pregnancy;
Advanced diabetes complications (end stage renal failure, registered blind, limb amputation);
Uncontrollable electrolyte disturbance, low blood pressure (<100/60mmHg), ECG abnormalities related to malnutrition (QTc-prolongation) or other physical conditions requiring inpatient treatment.