NCT01074762

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,470

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 1989

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1989

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1996

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
Last Updated

February 24, 2010

Status Verified

July 1, 2003

Enrollment Period

6.9 years

First QC Date

February 23, 2010

Last Update Submit

February 23, 2010

Conditions

Diabetes MellitusQuality of Health CareHealth Services Research

Keywords

Diabetes mellitusQuality of health careHealth services research

Outcome Measures

Primary Outcomes (5)

  • 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

  • Diabetic retinopathy

    Incidence of diabetic retinopathy

    at 6 year and 14 year after study start

  • Urinary albumin concentration

    Incidence of urinary albumin concentration \> 15 mg/l

    at 6 year and 14 year after study start

  • 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

  • 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

Secondary Outcomes (4)

  • New peripheral neuropathy

    at 6 year and 14 year after study start

  • New angina pectoris

    at 6 year and 14 year after study start

  • New intermittent claudication

    at 6 year and 14 year after study start

  • Amputation

    From diabetes diagnosis until median14 year after study start

Study Arms (1)

Routine general practice care

NO INTERVENTION

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.

Behavioral: Structured personal care

Interventions

Structured personal careBEHAVIORAL

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.

Routine general practice care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, Copenhagen, DK-1014, Denmark

Location

Related Publications (6)

  • 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.

    PMID: 31185995DERIVED

  • 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.

    PMID: 29216868DERIVED

  • 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.

    PMID: 26607637DERIVED

  • 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.

    PMID: 26602087DERIVED

  • 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.

    PMID: 24599111DERIVED

  • 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.

    PMID: 23549519DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

March 1, 1989

Primary Completion

February 1, 1996

Study Completion

February 1, 1996

Last Updated

February 24, 2010

Record last verified: 2003-07

Locations

DK(1)