Study of a Primary Care Hypoglycemia Prevention Program

NCT ID: NCT06353217

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2026-04-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient Involvement

Patients who participate in the study will undergo one Baseline Clinic Visit (baseline usual care), and one Intervention clinic visit.

Group Type: OTHER

Patient Group (Hypoglycemia Prevention Program)

Intervention Type: 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 Physician (PCP) Involvement

PCPs will be given access to the Hypoglycemia Prevention toolkit

Group Type: OTHER

Primary Care Physician Group

Intervention Type: 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.

Clinic Staff Involvement

Group Type: OTHER

Clinic Staff Group

Intervention Type: OTHER

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

Interventions

Patient Group (Hypoglycemia Prevention Program)

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.

Intervention Type: OTHER

Primary Care Physician Group

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.

Intervention Type: OTHER

Clinic Staff Group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Practicing at Johns Hopkins Internal Medicine Green Spring Station

• Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station

Exclusion Criteria

• 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

• Planning to leave their position prior to end of study
• Not serving as primary care provider for any included patient

• Planning to leave their position prior to end of study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott J Pilla, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

K23DK128572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00419034

Identifier Type: -

Identifier Source: org_study_id