Diabetes MellitusDCGPNCT01074762
Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
A study testing Structured personal care in people with Diabetes Mellitus and Quality of Health Care, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
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'… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Quality of Health Care, Health Services Research
- What is being tested?
- Structured personal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1989to Feb 1996
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5
Copenhagen, Copenhagen, DK-1014
About this study
Official 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.
Read the 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.
- Being tested
- Structured personal care
- Keywords
- Diabetes mellitus, Quality of health care, Health services research
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured personal careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Structured personal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From diabetes diagnosis until median14 year after study start
Diabetic retinopathy
Incidence of diabetic retinopathy
Measured: at 6 year and 14 year after study start
Urinary albumin concentration
Incidence of urinary albumin concentration > 15 mg/l
Measured: 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.
Measured: 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.
Measured: From diabetes diagnosis until median14 year after study start
Secondary outcomes (4)
New peripheral neuropathy
Measured: at 6 year and 14 year after study start
New angina pectoris
Measured: at 6 year and 14 year after study start
New intermittent claudication
Measured: at 6 year and 14 year after study start
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.
Measured: From diabetes diagnosis until median14 year after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 1989
- Primary completionFeb 1996
- Study completionFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074762
- Sponsor's protocol ID
- DCGP1989
- Acronym
- DCGP
- Status last verified
- Jul 2003
- First submitted
- 23 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31185995Heltberg 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.
PubMed 29216868Krag 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.
PubMed 26607637Larsen 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.
PubMed 26602087Lundstrom 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.
PubMed 24599111Hansen 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.
PubMed 23549519
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01074762
- Acronym / sponsor ID
- DCGP / DCGP1989
- Keywords
- Diabetes mellitus, Quality of health care, Health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,470 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Study start
- Mar 1989
- Primary completion
- Feb 1996 (actual)
- Study completion
- Feb 1996 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine general practice care | No intervention | Behavioral: Structured personal careIn 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured personal careGeneral 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. | Behavioural | Routine general practice care |
Primary outcome
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.
Diabetic retinopathy
Time frame: at 6 year and 14 year after study start
Incidence of diabetic retinopathy
Urinary albumin concentration
Time frame: at 6 year and 14 year after study start
Incidence of urinary albumin concentration > 15 mg/l
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.
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.
4 secondary outcomes
New peripheral neuropathy
Time frame: at 6 year and 14 year after study start
New angina pectoris
Time frame: at 6 year and 14 year after study start
New intermittent claudication
Time frame: at 6 year and 14 year after study start
Amputation
Time frame: From diabetes diagnosis until median14 year after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
- Derived from this study: PubMed 31185995Arreskov 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.
- Derived from this study: PubMed 29216868Heltberg 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.
- Derived from this study: PubMed 26607637Krag 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.
- Derived from this study: PubMed 26602087Larsen 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.
- Derived from this study: PubMed 24599111Lundstrom 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.
- Derived from this study: PubMed 23549519Hansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured personal care in people with Diabetes Mellitus and Quality of Health Care, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From diabetes diagnosis until median14 year after study start). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074762, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2010.