Study of a Primary Care Hypoglycemia Prevention Program (NCT06353217) | Clinical Trial Compass
CompletedNot Applicable
Study of a Primary Care Hypoglycemia Prevention Program
United States35 participantsStarted 2024-05-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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