Diabetes Mellitus Clinical Trial
— DCGPOfficial title:
The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
The aims of a concluding 14-year follow-up study are:
- To investigate what long-term effect the project model for structured, personalized
diabetes care has on 1) the patients' mortality and development of diabetic
complications, 2) the patients' use of services from the primary and secondary sector,
3) the patients' self-rated health and motivation, and 4) the doctor-patient
relationship.
Status | Completed |
Enrollment | 1470 |
Est. completion date | February 1996 |
Est. primary completion date | February 1996 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - all patients aged 40 or older with newly diagnosed diabetes between 1 March 1989 and 28 February 1991 based on hyperglycaemic symptoms or raised blood glucose values measured in general practice Exclusion Criteria: - threatening somatic disease, severe mental illness, or unwillingness to participate. For our analysis, we also excluded non-white patients and patients whose diagnosis was not established by a blood glucose measurement at a major laboratory within 500 days after diagnosis. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Denmark | The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5 | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Research Unit Of General Practice, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | The vital status of all patients was certified on the 31 January, 2006 through The Danish Civil Registration System (www.cpr.dk) which includes complete and continuously updated information on all Danish residents on vital status. | From diabetes diagnosis until median14 year after study start | No |
Primary | Diabetic retinopathy | Incidence of diabetic retinopathy | at 6 year and 14 year after study start | No |
Primary | Urinary albumin concentration | Incidence of urinary albumin concentration > 15 mg/l | at 6 year and 14 year after study start | No |
Primary | Myocardial infarction | Incidence of myocardial infarction. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005. | From diabetes diagnosis until median14 year after study start | No |
Primary | Stroke | Incidence of stroke. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005. | From diabetes diagnosis until median14 year after study start | No |
Secondary | New peripheral neuropathy | at 6 year and 14 year after study start | No | |
Secondary | New angina pectoris | at 6 year and 14 year after study start | No | |
Secondary | New intermittent claudication | at 6 year and 14 year after study start | No | |
Secondary | Amputation | Incidence of amputation. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005. | From diabetes diagnosis until median14 year after study start | No |
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