Study of a Primary Care Hypoglycemia Prevention Program
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 Start (Actual) 22 May 2024
🗓️ Primary Completion (Estimated) 14 April 2026
✅ Study Completion (Estimated) 14 April 2026
👥 Enrollment (Estimated) 35
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 April 2024
  • First Submitted that Met QC Criteria 5 April 2024
  • First Posted 9 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 6 June 2024
  • Last Verified June 2024