- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074762
Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus (DCGP)
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, DK-1014
- The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Routine general practice care
In the comparison group, doctors were free to choose any treatment and change it over time.
The study coordinating centre did not contact comparison practices after the end of recruitment (late 1991) until 1995.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: From diabetes diagnosis until median14 year after study start
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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.
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From diabetes diagnosis until median14 year after study start
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Diabetic retinopathy
Time Frame: at 6 year and 14 year after study start
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Incidence of diabetic retinopathy
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at 6 year and 14 year after study start
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Urinary albumin concentration
Time Frame: at 6 year and 14 year after study start
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Incidence of urinary albumin concentration > 15 mg/l
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at 6 year and 14 year after study start
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Myocardial infarction
Time Frame: From diabetes diagnosis until median14 year after study start
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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.
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From diabetes diagnosis until median14 year after study start
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Stroke
Time Frame: From diabetes diagnosis until median14 year after study start
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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.
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From diabetes diagnosis until median14 year after study start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New peripheral neuropathy
Time Frame: at 6 year and 14 year after study start
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at 6 year and 14 year after study start
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New angina pectoris
Time Frame: at 6 year and 14 year after study start
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at 6 year and 14 year after study start
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New intermittent claudication
Time Frame: at 6 year and 14 year after study start
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at 6 year and 14 year after study start
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Amputation
Time Frame: From diabetes diagnosis until median14 year after study start
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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.
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From diabetes diagnosis until median14 year after study start
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Collaborators and Investigators
Publications and helpful links
General Publications
- Arreskov AB, Olsen MA, Pouplier SS, Siersma V, Andersen CL, Friis S, de Fine Olivarius N. The impact of cancer on diabetes outcomes. BMC Endocr Disord. 2019 Jun 11;19(1):60. doi: 10.1186/s12902-019-0377-0.
- Heltberg A, Siersma V, Andersen JS, Ellervik C, Bronnum-Hansen H, Kragstrup J, de Fine Olivarius N. Socio-demographic determinants and effect of structured personal diabetes care: a 19-year follow-up of the randomized controlled study diabetes Care in General Practice (DCGP). BMC Endocr Disord. 2017 Dec 8;17(1):75. doi: 10.1186/s12902-017-0227-x.
- Krag MO, Hasselbalch L, Siersma V, Nielsen AB, Reventlow S, Malterud K, de Fine Olivarius N. The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care: a 13 year follow-up study. Diabetologia. 2016 Feb;59(2):275-85. doi: 10.1007/s00125-015-3804-4. Epub 2015 Nov 26.
- Larsen JR, Siersma VD, Davidsen AS, Waldorff FB, Reventlow S, de Fine Olivarius N. The excess mortality of patients with diabetes and concurrent psychiatric illness is markedly reduced by structured personal diabetes care: A 19-year follow up of the randomized controlled study Diabetes Care in General Practice (DCGP). Gen Hosp Psychiatry. 2016 Jan-Feb;38:42-52. doi: 10.1016/j.genhosppsych.2015.10.001. Epub 2015 Oct 19.
- Lundstrom H, Siersma V, Nielsen AB, Brodersen J, Reventlow S, Andersen PK, de Fine Olivarius N. The effectiveness of structured personal care of type 2 diabetes on recurrent outcomes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP). Diabetologia. 2014 Jun;57(6):1119-23. doi: 10.1007/s00125-014-3204-1. Epub 2014 Mar 6.
- Hansen LJ, Siersma V, Beck-Nielsen H, de Fine Olivarius N. Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP). Diabetologia. 2013 Jun;56(6):1243-53. doi: 10.1007/s00125-013-2893-1. Epub 2013 Apr 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCGP1989
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