Optimal Metabolic Health Through Continuous Glucose Monitoring (NCT04920058) | Clinical Trial Compass
CompletedNot Applicable
Optimal Metabolic Health Through Continuous Glucose Monitoring
United States66 participantsStarted 2021-05-10
Plain-language summary
The primary focus of this study is to evaluate the role of Continuous Glucose Monitoring (CGM) with Levels Health software as a tool to provide feedback and accountability necessary to create sustainable behavioral changes in nutrition associated with improved metabolic health and resilience against chronic and infectious diseases.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18-69 years of age
* Desire to improve metabolic health through nutritional, fitness, cognitive, and behavioral therapies.
* Voluntarily participate in either a live or virtual 12-week, multidisciplinary wellness program created and led by Allison Hull, DO.
* Body Mass Index (BMI) \> 20 kg/m2
* Fasting Blood Glucose (FBG) of 85-125 mg/dl
* HbA1c of 5.0-6.4 %
Exclusion Criteria:
* Type 1 or 2 Diabetes.
* Chronic Kidney Disease
* End Stage Liver Disease
* Use of any weight loss medications currently or in the past 3 months.
* Disordered Eating - anorexia or bulimia nervosa.
* Pregnant or Breastfeeding females.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glucose stability from baseline to 12 weeks as measured by Continuous Glucose Monitoring (CGM)
Timeframe: 12 weeks
2
Glucose stability from baseline to 12 weeks as measured by hemoglobin A1c (HbA1c)