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
Protocol serial number	RRCC701F R340152
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, metabolic and endocrine diseases: Diabetes
Intervention	Care package vs standard treatment
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/01/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Type II diabetic patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/01/1999
Date of final enrolment	10/01/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Netherlaw

Darlington
DL3 7SQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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