protocolSection identificationModule nctId: NCT06353217, orgStudyIdInfo id: IRB00419034, secondaryIdInfos id: K23DK128572, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DK128572, briefTitle: Study of a Primary Care Hypoglycemia Prevention Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2026-04-14, completionDateStruct date: 2026-04-14, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes Mellitus, conditions: Hypoglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre/post pilot study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Patient Group (Hypoglycemia Prevention Program), interventions name: Primary Care Physician Group, interventions name: Clinic Staff Group, outcomesModule primaryOutcomes measure: Overall acceptability to patients, primaryOutcomes measure: Overall acceptability to primary care providers, primaryOutcomes measure: Overall acceptability to clinic staff, otherOutcomes measure: Intervention coherence (patients), otherOutcomes measure: Opportunity costs (patients), otherOutcomes measure: Ethicality (patients), otherOutcomes measure: Affective attitude (patients), otherOutcomes measure: Burden (patients), otherOutcomes measure: Self-efficacy (patients), otherOutcomes measure: Perceived effectiveness (primary care providers), otherOutcomes measure: Intervention coherence (primary care providers), otherOutcomes measure: Opportunity costs (primary care providers), otherOutcomes measure: Affective attitude (primary care providers), otherOutcomes measure: Burden (primary care providers), otherOutcomes measure: Self-efficacy (primary care providers), otherOutcomes measure: Burden (clinic staff), otherOutcomes measure: Opportunity costs (clinic staff), otherOutcomes measure: Recruitment rate, otherOutcomes measure: Retention rate for second clinic visit, otherOutcomes measure: Continuous glucose monitoring (CGM) completion, otherOutcomes measure: Continuous glucose monitoring (CGM) wear time, otherOutcomes measure: Time needed to complete patient hypoglycemia profile, otherOutcomes measure: Duration of clinical visit, otherOutcomes measure: Patient completion of hypoglycemia assessment, otherOutcomes measure: Primary care provider use of provider hypoglycemia toolkit, otherOutcomes measure: Patient hypoglycemia burden on continuous glucose monitoring (CGM), otherOutcomes measure: Patient time below range on continuous glucose monitoring (CGM), otherOutcomes measure: Patient time above range on continuous glucose monitoring (CGM), otherOutcomes measure: Patient mean glucose on continuous glucose monitoring (CGM), otherOutcomes measure: Patient satisfaction with care, otherOutcomes measure: Patient activation, otherOutcomes measure: Patient self-reported hypoglycemic events, otherOutcomes measure: Changes to hypoglycemia-causing medications, otherOutcomes measure: Glucagon prescription, otherOutcomes measure: Continuous glucose monitoring (CGM) prescription, otherOutcomes measure: Change in Frequency of Referrals to Diabetes Self Management Training (DSMT), otherOutcomes measure: Frequency of hypoglycemia history discussions, otherOutcomes measure: Frequency of Hypoglycemia anticipatory guidance discussions, otherOutcomes measure: Frequency of Medication adherence discussions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Scott J Pilla, MD, MHS, role: CONTACT, phone: 908-768-0002, email: spilla1@jhmi.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False