Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education
NCT ID: NCT04306848
Last Updated: 2022-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-01-01
2022-03-01
Brief Summary
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Detailed Description
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In practice, a glycemic profile, consisting of multiple glucose measurements before and after meals throughout the day, has sometimes been helpful in educating patients concerning the effects of their eating habits on blood sugar levels.
Would temporary use (8-10 weeks) of a continuous glucose monitoring system (CGMs) be a useful adjunct during lifestyle education in patients with T2DM or PD?
The purpose of this feasibility study is to evaluate the effectiveness of a CGMs on a small sample of patients while they are enrolled in a lifestyle medicine class, to:
* identify any logistical issue involved
* verify that useful data can be obtained for analysis
* inform development of a larger controlled study
Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, 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.
The FDA approved CGMs utilizes a small filament-like probe that is entered into the skin and measures sugar levels of the interstitial fluid of the subcutaneous tissue. This correlates with blood glucose levels.
Daily, the subjects will enter data into their smart phone app, which will include:
* time of arising in the morning, and perceived quality of sleep
* time and description of food and beverages consumed
* time and description of physical activity
* time and description of stress management activities
* time and duration of naps
* bedtime
Once daily, the subject will complete a reflection entry in a diary on their glucose levels over the last 24 hours in relation to their logged lifestyle activities.
At the completion of the 8 sessions of The Lifestyle Medicine Clinic, participants will complete a survey asking open ended question concerning the use of the CGMs.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pilot
Eligible 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.
Temporary Continuous Glucose Monitoring System
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).
Interventions
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Temporary Continuous Glucose Monitoring System
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Memorial Health System
OTHER
Ohio University
OTHER
Responsible Party
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David Drozek
Associate Professor
Locations
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Marietta Memorial Hospital
Marietta, Ohio, United States
Countries
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Other Identifiers
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TBD-2
Identifier Type: -
Identifier Source: org_study_id
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