The failing diabetic patient: Who When and Why? Meeting the needs of the poorly controlled Type 2 diabetic patient in general practice

ISRCTN ISRCTN75706509
DOI https://doi.org/10.1186/ISRCTN75706509
Secondary identifying numbers RRCC701F R340152
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
15/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Jeavons
Scientific

Netherlaw
28 Stanhope Road
Darlington
DL3 7SQ
United Kingdom

Phone +44 (0)1325 380640

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, metabolic and endocrine diseases: Diabetes
InterventionCare package vs standard treatment
Intervention typeOther
Primary outcome measure1.1 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 measuresNot provided at time of registration
Overall study start date10/01/1999
Completion date10/01/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaType II diabetic patients
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/01/1999
Date of final enrolment10/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Netherlaw
Darlington
DL3 7SQ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2006 Yes No