Skip to main content
OpenTrials
Completed

NCT Number: NCT01074762

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5

Copenhagen, DK-1014, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured personal care

Behavioral

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.

Primary outcomes

  1. Mortality

    Time frame: From diabetes diagnosis until median14 year after study start

    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.

  2. Diabetic retinopathy

    Time frame: at 6 year and 14 year after study start

    Incidence of diabetic retinopathy

  3. Urinary albumin concentration

    Time frame: at 6 year and 14 year after study start

    Incidence of urinary albumin concentration > 15 mg/l

  4. Myocardial infarction

    Time frame: From diabetes diagnosis until median14 year after study start

    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.

  5. Stroke

    Time frame: From diabetes diagnosis until median14 year after study start

    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.

Secondary outcomes

  1. New peripheral neuropathy

    Time frame: at 6 year and 14 year after study start

  2. New angina pectoris

    Time frame: at 6 year and 14 year after study start

  3. New intermittent claudication

    Time frame: at 6 year and 14 year after study start

  4. Amputation

    Time frame: From diabetes diagnosis until median14 year after study start

    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.

Sponsors and collaborators

Lead sponsor

Research Unit Of General Practice, Copenhagen

Other

Registry information

Official study title

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

Acronym: DCGP

Important dates

Study start
1989
Primary completion
1996
Study completion
1996
First posted
Feb 24, 2010
Registry last updated
Feb 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.