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Study of a Primary Care Hypoglycemia Prevention Program

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Diabetes Mellitus, Hypoglycemia

NCT06353217

Johns Hopkins University

16 June 2024

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