Feasibility study to evaluate a psychological treatment to reduce diabetic ketoacidosis episodes

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33956728

Enrollment

Registered

2016-08-02

Start date

2016-08-02

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic ketoacidosis Nutritional, Metabolic, Endocrine Diabetic ketoacidosis

Interventions

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 des

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Contacts

Public ContactChristopher Garrett

christopher.garrett@kcl.ac.uk+44 20 3299 1350

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026