Diabetes Mellitus, Type 1STEADY-IINCT05140564
Safe Management of People With Type 1 Diabetes and EAting Disorders studY
A study testing STEADY intervention in people with Diabetes Mellitus, Type 1 and Eating Disorders, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Eating Disorders
- What is being tested?
- STEADY intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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
- Being tested
- STEADY intervention
- Keywords
- Type 1 diabetes, Eating disorder, Diabulimia, EDNOS
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding and Eating Disorders, Diabulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEADY interventionBehavioural
STEADY is a novel Cognitive Behavioural Therapy (CBT) based intervention for eating disorders in type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| STEADY intervention group | Experimental | Not described Receives: Behavioral: STEADY intervention |
| Treatment as usual group (control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c measured in mmol/mol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start18 Jan 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140564
- Sponsor's protocol ID
- 290033
- Acronym
- STEADY-II
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stadler M, Zaremba N, Harrison A, Brown J, Pillay D, Allan J, Tan R, Ayis S, Konstantara E, Treasure J, Hopkins D, Ismail K. Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial. Lancet Reg Health Eur. 2025 Jan 20;50:101205. doi: 10.1016/j.lanepe.2024.101205. eCollection 2025 Mar.
PubMed 39902232
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Management of People With Type 1 Diabetes and EAting Disorders studY - Phase II
- ClinicalTrials.gov ID
- NCT05140564
- Acronym / sponsor ID
- STEADY-II / 290033
- Conditions
- Diabetes Mellitus, Type 1, Eating Disorders
- Keywords
- Type 1 diabetes, Eating disorder, Diabulimia, EDNOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEADY intervention group | Experimental | Behavioral: STEADY intervention |
| Treatment as usual group (control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEADY interventionSTEADY is a novel Cognitive Behavioural Therapy (CBT) based intervention for eating disorders in type 1 diabetes. | Behavioural | STEADY intervention group |
Primary outcome
HbA1c
Time frame: 6 months
HbA1c measured in mmol/mol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 39902232Stadler M, Zaremba N, Harrison A, Brown J, Pillay D, Allan J, Tan R, Ayis S, Konstantara E, Treasure J, Hopkins D, Ismail K. Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial. Lancet Reg Health Eur. 2025 Jan 20;50:101205. doi: 10.1016/j.lanepe.2024.101205. eCollection 2025 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEADY intervention in people with Diabetes Mellitus, Type 1 and Eating Disorders, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.