Status:
COMPLETED
Acceptability of Virtual Educational Intervention for Adolescents and Young Adults With Type 1 Diabetes Mellitus
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
16-21 years
Phase:
NA
Brief Summary
In this pilot study, study investigators aim to evaluate the acceptability and feasibility of a 3-month interactive virtual educational program, designed on principles of self-efficacy, reviewing aspe...
Detailed Description
Background/Rationale: The landmark study Diabetes Control and Complications Trial (DCCT, 1982-1993) conclusively proved that intensive glycemic control causes a reduction in the early stages of all m...
Eligibility Criteria
Inclusion
- Age range: from 16 years to 21 years of age
- Type 1 Diabetes Mellitus (Anti-body positive) for at least one year
- Suboptimal glycemic control (HBA1C \> 8.5%) in the last 6 months
- Patients on insulin regimen involving multiple daily subcutaneous insulin injections (basal- bolus regimen) or insulin pumps (excluding hybrid close loop pumps)
Exclusion
- Non-English-Speaking patients
- Patients on insulin regimen involving mixed insulin with twice daily injections
- Patients who are planning to undergo any change in their insulin delivering technology or glucose monitoring device during the study time period i.e. planning initiation or discontinuation of pump or Continuous Glucose Meter.
- Patients who received new onset DM teaching at another institution and transferred care from other institutions later in their disease course.
- Individuals with other chronic medical conditions or underlying mental health conditions like eating disorders, schizophrenia or severe depression or inability to care for themselves in activities of daily living (ADLs), or impaired ability to participate in the research in the discretion of their primary diabetes provider.
- Patients lacking accessibility of a virtual platform for the intervention modules for a 3-month
- Patients with no visit with Diabetes care provider within the 6 months prior to screening for study eligibility
- Pregnancy (only if subject, at the time of recruitment, reports being pregnant or planning a pregnancy in the next 6 months. Pregnancy tests will not be performed as part of the study).
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04878419
Start Date
June 17 2021
End Date
May 1 2022
Last Update
October 28 2022
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106