Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/06/2007
Date assigned
07/06/2007
Last edited
13/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Thow

ORCID ID

Contact details

York Hospital
Wigginton Road
York
YO318HE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BITES1

Study information

Scientific title

Acronym

BITES

Study hypothesis

Our hypothesis was that the effectiveness of a brief (2.5-day) psycho-educational intervention for self-management in people with type 1 diabetes in a realistic clinical out-patient setting would be comparable to that of established longer interventions.

Ethics approval

Approved by York Research Ethics Commitee. Ref: 01/08/016

Study design

Pragmatic, randomised controlled trial. Secondary care setting.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Type 1 diabetes

Intervention

Brief Intervention in Type 1 Diabetes:
Education for Self-Efficacy Course (BITES), developed by a multi-disciplinary team including Consultant Diabetologist, Diabetes Specialist Nurse, Specialist Diabetes Dietician and Clinical Health Psychologist, and delivered as a 2.5-day course over a 6-week period to allow participants time to practice and reflect between sessions. The sessions were facilitated by a Diabetes Specialist Nurse and Specialist Diabetes Dietician.

The goal of BITES is to motivate and enable the patients to strive for blood glucose values as normal as possible. All those agreeing to participate will be asked to convert to a basal bolus insulin regime based on two injections of isophane insulin (morning and evening) and meal-related rapid acting insulin. Insulin dose adjustment skills will be based on the Dusseldorf and DAFNE (Dose Adjustment For Normal Eating) principles of treatment to target glucose and insulin matching to carbohydrate portions. The nutritional emphasis will be on normal eating and unrestricted patient choice.

The control group recieved standard care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following were meausred at 3, 6 and 12 months:
1. HbA1c
2. Severe Hypoglycaemia

Secondary outcome measures

The following were meausred at 3, 6 and 12 months:
1. Blood pressure
2. Weight
3. Height
4. Total cholesterol
5. Triglycerides
6. Psychological questionnaire with the following scales:
6.1. Short Form 36
6.2. Illness Perception Questionnaire (IPQ)
6.3. Diabetes Knowledge Test (DKT)
6.4. Diabetes Empowerment Scale (DES)
6.5. Diabetes Treatment Satisfaction Questionnaire (DTS-Q)
6.6. Hypoglycaemia Fear Scale (HFS)
6.7. Diabetes Health Profile (DHP)
6.8. Diabetes Self-Managing Adherence questionnaire (DSMA-Q)

Overall trial start date

01/06/2003

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were recruited from the Diabetes Centre of York Health Services NHS Trust. Eligibility criteria were:
1. Type 1 diabetes for longer than 12 months
2. Multiple injection therapy for at least two months
3. Minimum age 18
4. Able and willing to participate in the intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Children under age 18
2. Type 1 for less than 12 months
3. Incapacity to participate fully in the programme

Recruitment start date

01/06/2003

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York Hospital
York
YO318HE
United Kingdom

Sponsor information

Organisation

York Hospitals NHS Foundation Trust (UK)

Sponsor details

York Hospital
Wigginton Road
York
YO318HE
United Kingdom

Sponsor type

Government

Website

http://www.yorkhealthservices.org/

Funders

Funder type

Government

Funder name

York NHS Trust Research and Development Innovation Fund. (UK) (Ref 01/08/016)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol on http://www.ncbi.nlm.nih.gov/pubmed/17868462
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/19046244

Publication citations

  1. Results

    George JT, Valdovinos AP, Russell I, Dromgoole P, Lomax S, Torgerson DJ, Wells T, Thow JC, Clinical effectiveness of a brief educational intervention in Type 1 diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self-efficacy) trial., Diabet. Med., 2008, 25, 12, 1447-1453, doi: 10.1111/j.1464-5491.2008.02607.x.

  2. George JT, Valdovinos AP, Thow JC, Russell I, Dromgoole P, Lomax S, Torgerson DJ, Wells T, Brief Intervention in Type 1 diabetes - Education for Self-efficacy (BITES): Protocol for a randomised control trial to assess biophysical and psychological effectiveness., BMC Endocr Disord, 2007, 7, 6, doi: 10.1186/1472-6823-7-6.

Additional files

Editorial Notes