The project DiPS: Exceeding the cutoff value for blood glucose - what does that mean to you? Issue, offering and evaluation of an evidence based patient information about blood glucose testing and primary prevention of diabetes mellitus type 2
| ISRCTN | ISRCTN22060616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22060616 |
| Protocol serial number | 01EL0706 |
| Sponsor | German Diabetes Centre (Germany) |
| Funder | German Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung [BMBF]) (Germany) |
- Submission date
- 15/08/2008
- Registration date
- 12/09/2008
- Last edited
- 18/10/2012
- 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 Andrea Icks
Scientific
Scientific
German Diabetes Centre
Leibniz Centre for Diabetes Research
at Heinrich-Heine-University of Duesseldorf
Aufm Hennekamp 65
Duesseldorf
40225
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel-group cluster-randomised controlled interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Blood glucose testing and primary prevention of diabetes mellitus type 2 - evaluation of the effect of evidence based patient information: a parallel-group, cluster-randomised controlled interventional study |
| Study acronym | DIPS (Diabetes-Präventions-Check/Diabetes Prevention Check) |
| Study objectives | Current hypothesis as of 16/10/2009: The purpose of this study is a web-based evaluation of how evidence-based consumer information compared to standard information on elevated blood glucose levels screening and diabetes mellitus type 2 - prevention affects the quality of decision, defined by adequate knowledge and consistent with ones attitudes and intention. The measure is based on: 1. Knowledge about elevated blood glucose levels, metabolic testing, options of primary prevention of diabetes (primary outcome) 2. Attitudes to metabolic testing 3. Intention to undergo metabolic testing 4. Decision conflict about testing Furthermore: 5. Satisfaction with the information An evidence-based consumer information about elevated blood glucose levels is not available yet and developed within this project. Null Hypothesis: There is no statistical significant difference in knowledge between participants achieving evidence-based consumer information or standard information about elevated blood glucose levels. Initial hypothesis at time of registration: The purpose of this study is to determine how evidence based consumer information compared to standard information on pre-diabetes screening and diabetes prevention affects: 1. The uptake of pre-diabetes screening, and 2. The satisfaction with information delivery An evidence-based consumer information about pre-diabetes is not available yet. Null hypothesis: There is no statistical significant difference between participants achieving evidence-based consumer information or standard information about pre-diabetes. A power calculation was performed, considering participations of 30% (control group) and 50% (intervention group), yielding 16 companies and 1800 employees to be included. Please note as of 16/10/2009 this record has been substantially amended due to problems with recruitment and a subsequent change to the original protocol. All amendments can be found under the relevant section with the above update date. Please also note that at this time, the following fields have also been amended: 1. The titles of the trial were amended and an acronym added; the initial titles of this trial at the time of registration were: Initial public title: Efficacy of evidence-based consumer information on pre-diabetes screening: a randomised controlled trial Initial scientific title: Metabolic test for primary prevention of type 2 diabetes in elderly employees as part of workplace health promotion: evaluation of effects of evidence based patient information 2. The target number of participants field was updated; the initial target number of participants was "3696" 3. The study design was slightly amended; the initial study design was "a multicentre, parallel-group, cluster-randomised controlled interventional study" 4. The disease/condition/study domain field was slightly amended; the initial disease/condition/study design field was "Pre-diabetes in elderly employees" 5. The anticipated end date was slightly amended; the initial anticipated end date was 31/05/2010 As of 22/03/2012, the target number of participants have been updated from 2000 to 1054. |
| Ethics approval(s) | Ethics approval was received from the Ethics Committee of the University of Düsseldorf on the 28th February 2008. Amendments to the protocol were approved on the 7th August 2009 (ref: 3020) |
| Health condition(s) or problem(s) studied | Elevated blood glucose levels in the elderly population |
| Intervention | Current information as of 16/10/2009: Evidence-based consumer information compared to standard information, both provided as online information. Individual data are collected during an online session. Data of the primary and partly of the secondary endpoints are collected during the first online session. Two weeks later at a second individual online session, further secondary endpoint data are collected. Initial interventions at the time of registration: Evidence-based consumer information brochure/counselling compared to standard brochure/counselling. The intervention in each company will be about one month, depending of the size of the company. All companies will be contacted again in the end of the study at approximately 15 months after the first intervention. Added 21/10/2009: Contact details for cooperating partner of trial: Scientific Institute for Benefit and Efficiency in Health Care (WINEG) Habichtstrasse 30 22305 Hamburg Germany |
| Intervention type | Other |
| Primary outcome measure(s) |
Current information as of 16/10/2009: |
| Key secondary outcome measure(s) |
Current information as of 16/10/2009: |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1054 |
| Key inclusion criteria | Current inclusion criteria as of 22/03/2012 Aged 40 - 70 years, either sex Previous inclusion criteria as of 16/10/2009: Aged 50 - 70 years, either sex Initial inclusion criteria at the time of registration: 1. Employees of participating companies 2. Aged 50 or older, either sex |
| Key exclusion criteria | Current exclusion criteria as of 22/03/2012 1. Known to have diabetes mellitus 2. Aged younger than 40 years Previous exclusion criteria as of 16/10/2009: 1. Known to have diabetes mellitus 2. Aged younger than 50 years Initial exclusion criteria at the time of registration: 1. Employees of participating companies known to have diabetes mellitus 2. Aged younger than 50 3. Have no German language ability |
| Date of first enrolment | 01/12/2007 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
German Diabetes Centre
Duesseldorf
40225
Germany
40225
Germany
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 | 01/08/2012 | Yes | No | |
| Protocol article | protocol | 14/01/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
