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