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
Scientific
Netherlaw
28 Stanhope Road
Darlington
DL3 7SQ
United Kingdom
| Phone | +44 (0)1325 380640 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Not Specified |
| 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 | 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 study start date | 10/01/1999 |
| Completion date | 10/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Netherlaw
Darlington
DL3 7SQ
United Kingdom
DL3 7SQ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
