Diabetes care Implementation Study

ISRCTN	ISRCTN21523044
DOI	https://doi.org/10.1186/ISRCTN21523044
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (UMCU) (The Netherlands)
Funder	University Medical Centre Utrecht (UMCU) (The Netherlands)

Submission date: 02/05/2007
Registration date: 02/05/2007
Last edited: 04/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F.G.W. Cleveringa
Scientific

University Medical Centre Utrecht
Julius Centre for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3500 GA
Netherlands

Phone	+31 (0)30 253 8608
Email	f.g.w.cleveringa@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Diabetes care Implementation Study
Study acronym	DIS
Study objectives	Diabetes care can be improved by task delegation to a practice nurse supported by computerised decision support and benchmarking.
Ethics approval(s)	Received from the local ethics committee (Medical Ethics Committee, UMC-Utrecht) on the 24th February 2004 (ref: 03/233-E).
Health condition(s) or problem(s) studied	Diabetes Mellitus type two (DM2)
Intervention	Implementing the Diabetes Care Protocol (DCP) developed by Diagnosis 4 Health. Characteristics: consultation hour exclusively scheduled for DM2 patients and delegation of routine diabetes care tasks to a trained practice nurse who uses the DCP software that supports management and medical decisions.
Intervention type	Other
Primary outcome measure(s)	1. Change in: a. HbA1c % b. Blood pressure c. Total cholesterol The primary and secondary outcomes will all be measured at baseline and after one year follow-up.
Key secondary outcome measure(s)	1. Change in cardiovascular risk 2. Effects on quality of life and patient treatment satisfaction 3. Effects on process of care The primary and secondary outcomes will all be measured at baseline and after one year follow-up.
Completion date	30/05/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	3500
Total final enrolment	3391
Key inclusion criteria	Diabetes Mellitus type two (DM2)
Key exclusion criteria	1. Under treatment of medical specialist 2. Terminally ill patients 3. Patients with complex multi-morbidity 4. Patients not able to visit the general practice
Date of first enrolment	01/03/2004
Date of final enrolment	30/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Utrecht

Utrecht
3500 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008	04/01/2021	Yes	No

Editorial Notes

04/01/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.