Study of a Primary Care Hypoglycemia Prevention Program

NCT06353217 | Completed

• 2 other identifiers: IRB00419034K23DK128572
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.

Conditions

Diabetes Mellitus; Hypoglycemia

Outcome Measures

Primary Outcomes (3)

• Overall acceptability to patients

  Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

  Immediately after the intervention

• Overall acceptability to primary care providers

  Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

  Immediately after the intervention

• Overall acceptability to clinic staff

  Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

  Immediately after the intervention

Other Outcomes (41)

• Intervention coherence (patients)

  Immediately after the intervention

• Opportunity costs (patients)

  Immediately after the intervention

• Ethicality (patients)

  Immediately after the intervention

Study Arms (1)

Primary care hypoglycemia prevention program

OTHER

Other: Patient Group (Hypoglycemia Prevention Program); Other: Primary Care Physician Group; Other: Clinic Staff Group

Interventions

Patient Group (Hypoglycemia Prevention Program) OTHER

The Hypoglycemia Prevention Program: The patient hypoglycemia profile - this is a set of survey questions about hypoglycemia and related aspects of diabetes care. The questions will be administered as an Epic MyChart message sent to the patient in the week prior to the clinic visit, and in the clinic waiting room on a tablet immediately prior to the patient's primary care provider visit.

Primary care hypoglycemia prevention program

Primary Care Physician Group OTHER

The provider hypoglycemia toolkit - this is the report from the patient hypoglycemia profile, which triggers a set of hypoglycemia prevention tools and patient education materials as appropriate. Primary Care Providers will not be exposed to the intervention until all of their patients have completed the Baseline Clinic Visit.

Primary care hypoglycemia prevention program

Clinic Staff Group OTHER

Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit.

Primary care hypoglycemia prevention program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diabetes mellitus by electronic health record review
• Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides
• Community dwelling (not residing in long-term care or a skilled nursing facility)
• Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station
• The patient's primary care provider approves their participation

You may not qualify if:

• Significant cognitive impairment or dementia
• Receiving hospice or end of life care
• Any other serious illness or condition not compatible with participation as determined by the investigators
• Planning to leave area prior to end of study
• Investigator discretion
• History of allergic skin reaction to adhesive
• Implantable pacemaker
• Practicing at Johns Hopkins Internal Medicine Green Spring Station
• Planning to leave their position prior to end of study
• Not serving as primary care provider for any included patient
• Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station
• Planning to leave their position prior to end of study

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Scott J Pilla, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/post pilot study

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 9, 2024
• Study Start: May 22, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)