Diabetes Mellitus, Type 2OSI-DMNCT03160196
Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus.
A study testing Clinical Decision Support System in people with Diabetes Mellitus, Type 2, run by Sanitas University.
Trial summary
To assess the efficacy of an electronic system to support clinical decisions based on an evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Clinical Decision Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,768 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Sep 2019
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No prior exposure to the tool (through development and beta testing)
- Access to an organized diabetes pathway consistent with the Sanitas EPS (Entidad Promotora de Salud) diabetes mellitus 2 guideline.
Who cannot join
- Terminally ill
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of an Electronic System to Support Clinical Decisions Based on an Evidence-based Clinical Practice Guide for Metabolic Control of Adults With Type 2 Diabetes Mellitus: Clinical and Cluster-randomized Controlled Trial.
To assess the efficacy of an electronic system to support clinical decisions based on an evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Clinical Decision Support System, Usual care based on clinical practice guideline
- Keywords
- Diabetes Mellitus, Type 2, Hemoglobin A, Glycosylated
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support SystemOther
It is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline.
Usual care based on clinical practice guidelineOther
It is about usual care aligned with the diabetes guideline.
| Study group | Role | What they receive |
|---|---|---|
| Experimental practices | Experimental | The decision support tool is a Web-based software program accessed via a GP computer desktop icon. Clicking the icon opens a single page of tick boxes asking for relevant aspects of the presenting illness. Most fields for relevant medical history and patient demographics are automatically populated from data in the electronic health record. Depending on diagnosis and risk estimation, the tool recommends a guideline-based management strategy. Override options exist but require a justification from the GP. The tool also provides relevant prescriptions, radiology access, and referral forms, and a variety of patient information leaflets. GPs in practices randomized to the intervention group will have to initiate the tool but will not have to follow the tool's advice. Receives: Other: Clinical Decision Support System |
| Control practices | Active comparator | Control practices will be aware of the tool but will be unable to access it and managed patients by usual care, which could include care aligned with the Guidelines. Prior to randomization, GPs from all participating practices (control and intervention) will attend a 1-hour face-to-face didactic education session on diabetes mellitus 2 management and the Colombia diabetes mellitus 2 Guidelines. The intervention pertains to the cluster level. Receives: Other: Usual care based on clinical practice guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of participants with normal Hb1Ac
Measured: 6 months and a year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startJan 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanitas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abel Ernesto González Vélez, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160196
- Acronym
- OSI-DM
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Electronic System to Support Clinical Decisions Based on an Evidence-based Clinical Practice Guide for Metabolic Control of Adults With Type 2 Diabetes Mellitus: Clinical and Cluster-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03160196
- Acronym / sponsor ID
- OSI-DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Hemoglobin A, Glycosylated
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,768 participants (estimated)
- Lead sponsor
- Sanitas UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 May 2017 (actual)
- 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.
To assess the efficacy of an electronic system to support clinical decisions based on an evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental practices | Experimental | Other: Clinical Decision Support SystemThe decision support tool is a Web-based software program accessed via a GP computer desktop icon. Clicking the icon opens a single page of tick boxes asking for relevant aspects of the presenting illness. Most fields for relevant medical history and patient demographics are automatically populated from data in the electronic health record. Depending on diagnosis and risk estimation, the tool recommends a guideline-based management strategy. Override options exist but require a justification from the GP. The tool also provides relevant prescriptions, radiology access, and referral forms, and a variety of patient information leaflets. GPs in practices randomized to the intervention group will have to initiate the tool but will not have to follow the tool's advice. |
| Control practices | Active comparator | Other: Usual care based on clinical practice guidelineControl practices will be aware of the tool but will be unable to access it and managed patients by usual care, which could include care aligned with the Guidelines. Prior to randomization, GPs from all participating practices (control and intervention) will attend a 1-hour face-to-face didactic education session on diabetes mellitus 2 management and the Colombia diabetes mellitus 2 Guidelines. The intervention pertains to the cluster level. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No prior exposure to the tool (through development and beta testing)
- Access to an organized diabetes pathway consistent with the Sanitas EPS (Entidad Promotora de Salud) diabetes mellitus 2 guideline.
Key exclusion criteria (1 listed)
- Terminally ill
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 |
|---|---|---|
| Clinical Decision Support SystemIt is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline. | Other | Experimental practices |
| Usual care based on clinical practice guidelineIt is about usual care aligned with the diabetes guideline. | Other | Control practices |
Primary outcome
Proportions of participants with normal Hb1Ac
Time frame: 6 months and a year of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support System in people with Diabetes Mellitus, Type 2, run by Sanitas University.
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 2 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: status not confirmed, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abel González, PhD (+573132578216, abegonzalez@colsanitas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of participants with normal Hb1Ac (time frame: 6 months and a year of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2017.