Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/07/2016
Date assigned
02/08/2016
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 1 diabetes mellitus (T1DM) is a lifelong condition where a person is unable to prevent their blood sugar (glucose) levels from becoming too high. When a person is suffering from TD1M, the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. The only effective way of treating T1DM is by regularly injecting the insulin that the body is unable to produce. It is very important that sufferers take their insulin regularly, as otherwise it can lead to serious complications. Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of T1DM. When glucose cannot be used for energy because there isn’t enough insulin, the body starts to break down fats. This causes toxic chemicals called ketones to build up in the body which if left untreated, can lead to coma and death. It has been found that T1DM patients who suffer from other illnesses, are more likely to suffer repeated episodes of DKA (recurrent DKA, rDKA) because of not taking insulin or not managing to balance their medication with their lifestyle well enough (disease management). Mentalization-based therapy (MBT) is a type of talking therapy which aims to improve behavioural control, better regulation of emotions, improving personal relationships, and increasing the ability to achieve goals in life. The aim of this study is to assess the feasibility of using MTB as a treatment for diabetic patients with rDKA.

Who can participate?
Adults with T1DM and have had two or more admissions to hospital for diabetic ketoacidosis in the last 12 months.

What does the study involve?
In the first part of the study, four diabetes departments in south-east London are asked to count the numbers of potential participants (adults with T1DM who have rDKA) admitted, and the number of those who are transferred to intensive care units. In the second part of the study, participants are offered 40 weekly individual 50 minute mentalization based therapy (MBT) sessions, held at the King's College Hospital diabetes clinic. The participants are followed up at 3 months at which point the number of DKA episodes will be counted as well as having a blood test to test their blood sugar control. Participants also complete a number of questionnaires to assess their mental wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from a lower risk of suffering episodes of diabetic ketoacidosis in the future and improvements to their mental wellbeing which is likely to improve their blood sugar control. The main risk is that the program may not succeed and diabetic ketoacidosis admissions continue to occur.

Where is the study run from?
King's College Hospital (lead centre) and five other NHS hospital in London (UK)

When is the study starting and how long is it expected to run for?
June 2013 to September 2017

Who is funding the study?
Novo Nordisk UK Research Foundation (UK)

Who is the main contact?
Dr Christopher Garrett
christopher.garrett@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Christopher Garrett

ORCID ID

http://orcid.org/0000-0003-4425-6609

Contact details

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
+44 20 3299 1350
christopher.garrett@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

004

Study information

Scientific title

Pre and Post Feasibility study to evaluate an attachment focused psychological treatment to reduce DKA episodes

Acronym

Study hypothesis

The aim of this study is to find out whether adequate numbers of participants can be recruited to a study using a psychological intervention for diabetic ketoacidosis.

Ethics approval

South Birmingham Research Ethics Committee, 07/07/2016

Study design

Pre and post non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Diabetic ketoacidosis

Intervention

Part A:
The first part of the trial will assess whether a randomised controlled trial would get sufficient referrals from units in a 10 mile catchment area. This section of the study uses a survey design. NHS Diabetes services within approximately 10 mile catchment area of King's College Hospital will be contacted by email to request involvement. Survey data requested will include numbers of DKA admissions, numbers of rDKA admissions with number of admissions reaching intensive care units. The standardised questionnaire has also been designed to ascertain how rDKA is currently managed and willingness to refer to a study investigating a psychological intervention for rDKA.

Part B:
Patients will be offered 40 weekly individual 50 minute mentalization based therapy (MBT) sessions, by a clinician trained in MBT and experienced in managing complex physical and mental health problems. Supervision will be with a consultant psychiatrist experienced in supervising MBT. These sessions will be held at King's College Hospital in the diabetes clinic. The sessions involve involve Mentalization Based Therapy which is a NICE recommended psychoanalytically orientated psychotherapy used in personality disorder treatment focusing on interpersonal functioning and affect regulation, but in this setting will also be used to help participants to reflect on their relationship with type 1 diabetes.

The participants are followed up at 3 months at which point the number of DKA episodes will be counted as well as a biochemical assessment of insulin omission using HbA1c and behavioural assessment with a count of numbers of tests/day and numbers of boluses/day. The battery of psychological assessments will also be repeated and compared with initial assessment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility outcomes:
1. Eligibility rate is measured by numbers of patients across 6 sites having 2 or more DKA episodes in last year
2. Recruitment rate is measured by number of patients recruited over number of patients assessed
3. Clinician willingness to recruit participants is measured by number of patients they would refer over TOTAL number eligible
4. Attrition rate is measured by the number of participants who consent to participate that remain in the study until follow-up at 3 months

Secondary outcome measures

1. Glycated hemoglobin (HbA1c) is measured using a HbA1c test at baseline and 3 months
2. Average blood glucose is measured using a blood glucose monitor at baseline and for the 2 weeks prior to 3 months follow-up
3. Tests/day is measured as number of tests done at baseline and for the 2 weeks prior to 3 months follow-up
3. Boluses/day is measured as recorded boluses on electronic meter at baseline and for the 2 weeks prior to 3 months follow-up
4. Depression symptoms are measured using the Becks depression inventory at baseline and 3 months
5. Anxiety symptoms is measured using the Becks anxiety inventory at baseline and 3 months
6. Interpersonal functioning is measured using IIP 32 at baseline and 3 months
7. Reflective functioning is measured using RFQ54 at baseline and 3 months

Overall trial start date

01/06/2013

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Two or more admissions for diabetic ketoacidosis in the last 12 months
2. Type 1 diabetes
3. Over 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Diagnosis of type 1 diabetes for less than 12 months
2. DKA admissions secondary to other types of diabetes (type 2 diabetes, gestational diabetes)
3. Established diagnosis of psychotic illness
4. Established diagnosis of alcohol dependence disorder or other substance misuse disorder
5. Established IQ < 70
6. Already receiving psychological intervention


Recruitment start date

02/08/2016

Recruitment end date

12/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill
London
SE5 9RJ
United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Princess Royal University Hospital
Farnborough Common
Orpington
BR6 8ND
United Kingdom

Trial participating centre

University Hospital Lewisham
Lewisham High Street Lewisham
London
SE13 6LH
United Kingdom

Trial participating centre

Croydon University Hospital
530 London Road Croydon
London
CR7 7RE

Trial participating centre

Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

Sponsor type

University/education

Website

www.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Novo Nordisk UK Research Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a healthcare journal within one year of last data collection at follow-up.

Intention to publish date

30/09/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes