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OpenTrials
Completed

NCT Number: NCT04177147

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical decision support via alert tool

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued

    Time frame: Five-month follow-up period

    Prescriptions for insulin and sulfonylurea drugs are assessed

Other outcomes

  1. Number of participants with inpatient or outpatient medical encounters

    Time frame: Five-month follow-up period

    Includes emergency encounters

  2. Number of participants undergoing patient education related to diabetes

    Time frame: Five-month follow-up period

    Text analysis of medical encounter notes

  3. Number of A1c, glucose, and creatinine blood tests

    Time frame: Five-month follow-up period

    Mean and SD

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: HG_Tool

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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