Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education

Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education for People With Type 2 Diabetes: a Feasibility Study.

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).

Study Overview

• Status: Withdrawn
• Conditions: Blood Glucose Profile
• Intervention / Treatment: Device: Temporary Continuous Glucose Monitoring System

Detailed Description

Glucose peaks after eating are an indication of the level of insulin resistance and the severity of disease in patients with T2DM. Many lifestyle factors affect the glucose elevation, including the glycemic index of food, timing of eating, physical activity, stress and sleep.

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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 Names: Intensive therapeutic lifestyle medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose profile	The blood glucose profile will be evaluated for out of range values	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
participant survey	Specifically concerning the Diabits software:What did you like about Diabits?What didn't you like about Diabits?Do you think Diabits has improved your blood sugar management?; Did you complete the data entry most of the time? If not, please explain, and make suggestions on how the experience could be improved.; Did you have any difficulty managing the sensor or device? If so, please explain, and make suggestions on how the experience could be improved.; Overall, did you feel that the continuous glucose monitoring system was helpful? Please explain your answer. How was it helpful or unhelpful?; What else should we know or would you like to tell us?	12 weeks

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: Memorial Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: continuous glucose monitoring, lifestyle medicine
• Other Study ID Numbers: TBD-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be posted after completion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes