Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— DCGP  

Official title:

The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074762
• Other study ID #: DCGP1989
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: February 23, 2010
• Start date: March 1989
• Est. completion date: February 1996

Study information

• Verified date: July 2003
• Source: Research Unit Of General Practice, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Type 2 diabetes (T2DM) is an increasingly common illness that is linked to considerable excessive mortality. There are many indications that treatment of raised blood pressure and blood glucose as well as dyslipidaemia can postpone the development of diabetic complications. Treatment of T2DM is primarily done in general practice, where the results are not satisfactory. The purpose of the project is to create a basis so the existing research-based knowledge can be used to improve the quality of diabetes care in general practice.

The answer will be based on the information from 1,428 newly diagnosed diabetic patients aged 40 or over who were followed since 1989 in a randomised trial among more than 600 general practitioners. The intervention, which ended at the beginning of 1996, provided optimum conditions for follow-up, doctor-patient communication and treatment, among other ways by training the doctors, producing clinical guidelines and setting individual treatment goals. In the project, the general practitioner is seen as the coordinator of the whole health system's prophylactic efforts in relation to the individual diabetic patient.

The aims of a concluding 14-year follow-up 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Health Services Research
• Quality of Health Care

Intervention

Behavioral:
• Structured personal care
General practitioners (GPs) were recommended to perform regular follow up every three months and an annual screening for diabetic complications. The GP was requested to define, together with the patient, the best possible goals for blood glucose concentration, glycated haemoglobin (HbA1c), diastolic blood pressure, and lipids within three predefined categories. At each quarterly consultation, the GP was asked to compare the achievements with the goal and consider changing either goal or treatment accordingly. The doctors received annual descriptive feedback reports on individual patients. The GPs were introduced to possible solutions to therapeutic problems through clinical guidelines supported by an annual half day seminar. Patient leaflets were produced for the doctor to hand out.

Locations

Country	Name	City	State
Denmark	The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Research Unit Of General Practice, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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