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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. Protocol on http://www.ncbi.nlm.nih.gov/pubmed/17868462
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/19046244
Publication citations
-
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.
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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.