| Source of record | UK Trials |
| ISRCTN | ISRCTN75706509 |
| Date ISRCTN assigned | 23/01/2004 |
| Local reference number(s) | RRCC701F R340152 |
| Public title | The failing diabetic patient: Who When and Why? Meeting the needs of the poorly controlled Type 2 diabetic patient in general practice |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, metabolic and endocrine diseases: Diabetes |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Type II diabetic patients |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 10/01/1999 |
| Anticipated end date | 10/01/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Not provided at time of registration |
| 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | NHS Executive Northern and Yorkshire |
| Sponsor name | NHS R&D Regional Programme Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr David Jeavons |
| Contact details | Netherlaw
28 Stanhope Road
Darlington
United Kingdom
DL3 7SQ |
| Contact telephone | +44 01325 380640 |
| Contact fax | +44 01325 350938 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75706509 |
| Date last extracted from ISRCTN register | 17/04/2008 |
