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

March 4, 2024 updated by: King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults (≥18 years);
  2. Diagnosis of type 1 diabetes mellitus for at least 6 months;
  3. 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.
  4. 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;
  5. Prepared to take part in the control group - treatment as usual (TAU)
  6. 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;
  7. Currently under the care of a diabetes specialist team (as this study does not replace usual diabetes care);
  8. 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);
  9. Investigator has confidence that the participant is able to fulfill all of the trial protocol requirements;
  10. Participant has capacity to consent to the study. This is assessed by ability to explain information about their involvement in the study.

Exclusion Criteria:

  1. HbA1c >15%/ 140.4 mmol/mol;
  2. More than 2 admissions for DKA in the past 12 months;
  3. 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);
  4. 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.);
  5. Body mass index below 15kg/m2 or above 40kg/m2;
  6. Significant cognitive impairment, e.g. dementia, learning disability;
  7. Unable to speak/hear/understand/read/write in English;
  8. Unable to give written informed consent;
  9. Pregnant or planning pregnancy;
  10. Advanced diabetes complications (end stage renal failure, registered blind, limb amputation);
  11. Uncontrollable electrolyte disturbance, low blood pressure (<100/60mmHg), ECG abnormalities related to malnutrition (QTc-prolongation) or other physical conditions requiring inpatient treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
HbA1c measured in mmol/mol
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on STEADY intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe