Study of a Primary Care Hypoglycemia Prevention Program

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus; Hypoglycemia
• Interventions: Other: Clinic Staff Group; Other: Primary Care Physician Group; Other: Patient Group (Hypoglycemia Prevention Program)

• Registration Number: NCT06353217
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-09
• Study Start: 2024-05-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-04-14
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic Staff Involvement	Clinic Staff Group	-
Primary Care Physician (PCP) Involvement	Primary Care Physician Group	PCPs will be given access to the Hypoglycemia Prevention toolkit
Patient Involvement	Patient Group (Hypoglycemia Prevention Program)	Patients who participate in the study will undergo one Baseline Clinic Visit (baseline usual care), and one Intervention clinic visit.

Primary Outcome Measures

Name	Time	Method
Overall acceptability to clinic staff	Immediately after the intervention	Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Overall acceptability to primary care providers	Immediately after the intervention	Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Overall acceptability to patients	Immediately after the intervention	Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States