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Behavioural Intervention
Hypoglycemia Prevention Program for Low Blood Sugar
N/A
Recruiting
Led By Scott J Pilla, MD, MHS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after the intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a program that helps prevent low blood sugar in patients taking medications that can cause it. The study will assess how well the program is accepted and if it is feasible in a primary
Who is the study for?
This trial is for individuals with low blood sugar or diabetes who are currently on medications that can cause hypoglycemia. Details about specific inclusion and exclusion criteria are not provided, but typically participants need to meet certain health conditions.
What is being tested?
The study tests a new program aimed at preventing low blood sugar in patients. It involves groups of primary care physicians, patients, and clinic staff working together. The goal is to see if the program works well in a real-world setting before planning a larger trial.
What are the potential side effects?
Since this trial focuses on a prevention program rather than medication, it may not have direct side effects like drugs do. However, changes in how low blood sugar is managed could potentially lead to varying levels of blood sugar control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall acceptability to clinic staff
Overall acceptability to patients
Overall acceptability to primary care providers
Other study objectives
Affective attitude (patients)
Affective attitude (primary care providers)
Burden (clinic staff)
+33 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Primary Care Physician (PCP) InvolvementExperimental Treatment1 Intervention
PCPs will be given access to the Hypoglycemia Prevention toolkit
Group II: Patient InvolvementExperimental Treatment1 Intervention
Patients who participate in the study will undergo one Baseline Clinic Visit (baseline usual care), and one Intervention clinic visit.
Group III: Clinic Staff InvolvementExperimental Treatment1 Intervention
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,384 Total Patients Enrolled
46 Trials studying Hypoglycemia
21,146 Patients Enrolled for Hypoglycemia
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,775 Total Patients Enrolled
3 Trials studying Hypoglycemia
61 Patients Enrolled for Hypoglycemia
Scott J Pilla, MD, MHSPrincipal InvestigatorJohns Hopkins University
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