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Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care

Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04177147
Acronym
HG_Tool
Enrollment
220
Registered
2019-11-26
Start date
2016-01-14
Completion date
2016-09-30
Last updated
2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypoglycemia

Keywords

Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records

Brief 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.

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.

Interventions

OTHERClinical decision support via alert tool

The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The study included clinicians who were scheduled to provide primary care during the four-month intervention period. Inclusion Criteria for patients: * Being at least 21 years of age * Have been prescribed or dispensed a drug for diabetes mellitus

Exclusion criteria

for patients: N/A

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with hypoglycemia during the study periodFive-month follow-up periodParticipants with hypoglycemia had blood glucose level less than 70 mg/dL

Secondary

MeasureTime frameDescription
Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinuedFive-month follow-up periodPrescriptions for insulin and sulfonylurea drugs are assessed

Other

MeasureTime frameDescription
Number of participants with inpatient or outpatient medical encountersFive-month follow-up periodIncludes emergency encounters
Number of participants undergoing patient education related to diabetesFive-month follow-up periodText analysis of medical encounter notes
Number of A1c, glucose, and creatinine blood testsFive-month follow-up periodMean and SD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026