Study of a Primary Care Hypoglycemia Prevention Program

Johns Hopkins University

Status: Active, not recruiting

Conditions: Hypoglycemia; Diabetes Mellitus

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06353217

IRB00419034

K23DK128572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients:

• 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

Exclusion criteria for patients:

• 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

Exclusion Criteria for continuous glucose monitoring (not required for study participation):

• History of allergic skin reaction to adhesive
• Implantable pacemaker

Inclusion criteria for primary care providers:

• Practicing at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for primary care providers:

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

Inclusion criteria for clinic staff:

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

Exclusion criteria for clinic staff

• Planning to leave their position prior to end of study

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

Patient Involvement

Other group

Description:

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

Treatment:

Other: Patient Group (Hypoglycemia Prevention Program)

Primary Care Physician (PCP) Involvement

Other group

Description:

PCPs will be given access to the Hypoglycemia Prevention toolkit

Treatment:

Other: Primary Care Physician Group

Clinic Staff Involvement

Other group

Treatment:

Other: Clinic Staff Group