Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC701F R340152
Study information
Scientific title
Acronym
Study hypothesis
1. To describe the characteristics of Type 2 diabetic patients with poor glycaemic control on oral therapy and ascertain any factors influencing referral for insulin therapy.
2. To ascertain patient and general practitioner beliefs and attitudes, fears and perceptions towards initiating insulin therapy in diabetic patients poorly controlled on oral treatment.
3. To develop a care package, incorporating these views, for the management of diabetic patients with poor control on oral therapy.
4. To evaluate the effect of a care package for general practice management of diabetic patients with poor control on oral treatment.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, metabolic and endocrine diseases: Diabetes
Intervention
Care package vs standard treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1.1 Characteristics of patients (age, sex, BMI, duration of diabetes, co-morbidity and other clinical features).
1.2 Description of therapy, type and duration.
1.3 Level of diabetic control (HbA1c), duration of oral treatment failure and time to initiation of insulin treatment.
2.1 Ascertainment of factors influencing general practice management and/or hospital referral of diabetic patients with failure of oral treatment.
2.2 Ascertainment of patient and general practitioner attitudes, beliefs, fears and perceptions towards failure of oral treatment and potential insulin therapy.
3. A simple care package for general practice management of the diabetic patient failing on oral treatment.
4.1 Level of glycaemic control before and after the intervention (glycosylated haemoglobin, HbA1c).
4.2 Quality of life assessment before and after the intervention.
4.3 Alteration in use of insulin treatment following introduction of the management package.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/01/1999
Overall trial end date
10/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Type II diabetic patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/01/1999
Recruitment end date
10/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Netherlaw
Darlington
DL3 7SQ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16679475/
Publication citations
-
Jeavons D, Hungin AP, Cornford CS, Patients with poorly controlled diabetes in primary care: healthcare clinicians' beliefs and attitudes., Postgrad Med J, 2006, 82, 967, 347-350, doi: 10.1136/pgmj.2005.039545.