HypoglycemiaHG_ToolNCT04177147
Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
A study testing Clinical decision support via alert tool in people with Hypoglycemia and Diabetes Mellitus, run by Indiana University.
Trial summary
Hypoglycemia (HG) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. This study will test the implementation of a computerized alert tool for clinicians. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus
- What is being tested?
- Clinical decision support via alert tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2016to 30 Sep 2016
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being at least 21 years of age
- Have been prescribed or dispensed a drug for diabetes mellitus
Who cannot join
- N/A
About this study
Hypoglycemia (HG) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. This study will test the implementation of a computerized alert tool for clinicians.
Read the detailed description
Diabetes mellitus is one of the most common non-communicable diseases worldwide and is a major cause of morbidity and mortality. An estimated 346 million people had diabetes in 2011, and diabetes is predicted to become the seventh leading cause of death in the world by the year 2030. In the United States, the incidence of diabetes nearly tripled between 1990 and 2010, with 1.9 million new cases diagnosed in 2010. Hypoglycemia (HG) is recognized as a limiting factor in optimal glycemic management of patients with diabetes. This potentially costly condition, occurring in approximately 20% to 60% of patients who receive oral medications for diabetes, threatens patient safety, quality of life, and potentially, cardiovascular health. Investigators have identified risk factors for HG, built a risk calculator for use by clinicians, integrated the calculator into the G3 electronic medical record system, and demonstrated our ability to collect data about outcomes. In this project, investigators studied the outcomes of implementing the risk calculator tool into clinical practice in ambulatory primary care. The findings and tools developed from this project will promote improved patient safety and medical care for diabetes.
- Conditions
- Hypoglycemia, Diabetes Mellitus
- Being tested
- Clinical decision support via alert tool
- Keywords
- Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support via alert toolOther
The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| Clinical decision support via alert tool | Experimental | Clinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia. Receives: Other: Clinical decision support via alert tool |
| Usual care | No intervention | Clinicians did not receive access to the electronic alert tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hypoglycemia during the study period
Participants with hypoglycemia had blood glucose level less than 70 mg/dL
Measured: Five-month follow-up period
Secondary outcomes (1)
Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued
Prescriptions for insulin and sulfonylurea drugs are assessed
Measured: Five-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start14 Jan 2016
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Model description
- Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Weiner, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177147
- Sponsor's protocol ID
- Merck RI 22
- Acronym
- HG_Tool
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weiner M, Cummins J, Raji A, Ofner S, Iglay K, Teal E, Li X, Engel SS, Knapp K, Rajpathak S, Baker J, Chatterjee AK, Radican L. A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution. Curr Med Res Opin. 2020 Apr;36(4):583-593. doi: 10.1080/03007995.2020.1717451. Epub 2020 Feb 6.
PubMed 31951747
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
- ClinicalTrials.gov ID
- NCT04177147
- Acronym / sponsor ID
- HG_Tool / Merck RI 22
- Conditions
- Hypoglycemia, Diabetes Mellitus
- Keywords
- Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 26 Nov 2019 (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.
Hypoglycemia (HG) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. This study will test the implementation of a computerized alert tool for clinicians.
Detailed description
Diabetes mellitus is one of the most common non-communicable diseases worldwide and is a major cause of morbidity and mortality. An estimated 346 million people had diabetes in 2011, and diabetes is predicted to become the seventh leading cause of death in the world by the year 2030. In the United States, the incidence of diabetes nearly tripled between 1990 and 2010, with 1.9 million new cases diagnosed in 2010. Hypoglycemia (HG) is recognized as a limiting factor in optimal glycemic management of patients with diabetes. This potentially costly condition, occurring in approximately 20% to 60% of patients who receive oral medications for diabetes, threatens patient safety, quality of life, and potentially, cardiovascular health. Investigators have identified risk factors for HG, built a risk calculator for use by clinicians, integrated the calculator into the G3 electronic medical record system, and demonstrated our ability to collect data about outcomes. In this project, investigators studied the outcomes of implementing the risk calculator tool into clinical practice in ambulatory primary care. The findings and tools developed from this project will promote improved patient safety and medical care for diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus
| Arm | Type | Receives |
|---|---|---|
| Clinical decision support via alert tool | Experimental | Other: Clinical decision support via alert toolClinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia. |
| Usual care | No intervention | –Clinicians did not receive access to the electronic alert tool. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being at least 21 years of age
- Have been prescribed or dispensed a drug for diabetes mellitus
Key exclusion criteria (1 listed)
- N/A
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 via alert toolThe alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus. | Other | Clinical decision support via alert tool |
Primary outcome
Number of participants with hypoglycemia during the study period
Time frame: Five-month follow-up period
Participants with hypoglycemia had blood glucose level less than 70 mg/dL
1 secondary outcome
Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued
Time frame: Five-month follow-up period
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 26 Nov 2019.
- Derived from this study: PubMed 31951747Weiner M, Cummins J, Raji A, Ofner S, Iglay K, Teal E, Li X, Engel SS, Knapp K, Rajpathak S, Baker J, Chatterjee AK, Radican L. A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution. Curr Med Res Opin. 2020 Apr;36(4):583-593. doi: 10.1080/03007995.2020.1717451. Epub 2020 Feb 6.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support via alert tool in people with Hypoglycemia and Diabetes Mellitus, run by Indiana 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: finished, as of the sponsor's last update on 26 Nov 2019. 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?
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?
Number of participants with hypoglycemia during the study period (time frame: Five-month follow-up period). 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 NCT04177147, which also lists 1 linked publication.
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 26 Nov 2019.