Study Stopped
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Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 25, 2022
March 1, 2022
1.2 years
March 11, 2020
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose profile
The blood glucose profile will be evaluated for out of range values
12 weeks
Secondary Outcomes (1)
participant survey
12 weeks
Study Arms (1)
Pilot
EXPERIMENTALEligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, an intensive therapeutic lifestyle medicine program, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities.
Interventions
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in an intensive therapeutic lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
Eligibility Criteria
You may qualify if:
- be able to read and write English.
- be enrolled in The Lifestyle Medicine Clinic, taught by Dr. Drozek
- be diagnosed with type 2 diabetes (T2DM) or prediabetes (PDM)
- be at least 18 years of age
- be comfortable wearing a sensor continuously for up to 10 weeks
- have a smart phone and be comfortable utilizing apps
- be able and willing to daily enter data concerning food consumed, exercise, stress management activities and sleep.
- be willing to complete a daily reflection on the relationship of their blood sugar to lifestyle activities.
- be willing to complete a survey at the completion of the project about their perceptions of utilizing continuous glucose monitoring (CGM)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio Universitylead
- Memorial Health Systemcollaborator
Study Sites (1)
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 13, 2020
Study Start
January 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
March 25, 2022
Record last verified: 2022-03