The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication

October 4, 2021 updated by: Daniel Cox, PhD, University of Virginia

The Use of Libre to Educate, Motivate and Activate Adults With Newly Diagnosed Type 2 Diabetes to Improve Metabolic Control and Reduce Their Reliance on Medication: A Pilot Study

GEM (Glycemic Excursion Minimization) is a new lifestyle treatment for type 2 diabetes that aims to lower glucose levels after meals and snacks. This is different from the current lifestyle treatment, which is to lose weight. This study is trying to find out if people who are newly diagnosed with type 2 diabetes can use a continuous glucose monitor together with the GEM lifestyle to improve control of their diabetes. Study participants will follow the GEM lifestyle for 4 months (1 month of treatment and 3 months of maintenance) instead of seeking usual care (medications or weight loss programs) to lower blood glucose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For people who are newly diagnosed with Type 2 Diabetes (T2D), it might be possible to delay or prevent the need for diabetic medications by reducing postprandial glucose (PPG). Our Glycemic Excursion Minimization (GEM) lifestyle intervention can reduce PPG, but it depends on blood glucose feedback to help the user learn what elevates their PPG. This study examines if continuous feedback from the Libre 2 continuous glucose monitor (CGM) will be advantageous for reaching the goals of GEM. We will recruit 18 adult participants newly diagnosed with type 2 diabetes who are interested in using the Libre 2 CGM. Six participants will be recruited from each of the primary care clinics at the University of Virginia (Dr. Cox), the University of Colorado (Dr. Oser) and the University of West Virginia, East Branch (Dr. Cucuzzella). Each site will also search their medical records to select 4 participants who match their study participants, meet the study criteria, but are being treated with routine care. These data will form the Routine Care control group (n=12). Routine Care participants will follow their doctor's treatment recommendations, while GEM participants will complete the 1-month, self-directed GEM lifestyle training using the Libre 2 CGM and a FitBit to monitor progress. They will then maintain the GEM lifestyle for 3 more months. The Total Treatment Effect (a measure of treatment effectiveness that considers both A1c and medication changes) will be calculated pre- and post-treatment from medical record data. CGM data from GEM participants will be collected and analyzed. CGM sensor use will be tracked to estimate participant engagement. We anticipate this multi-center pilot project will demonstrate the benefits of using Libre 2 with a structured lifestyle intervention designed to reduce postprandial blood glucose excursions for individuals newly diagnosed with T2D.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:(GEM group)

  1. Provision of signed and dated informed consent form.
  2. Willing to comply with study procedures and be available for the entire study.
  3. 35 to 85 years of age, inclusive.
  4. Diagnosed with Type 2 Diabetes within the last 12 months.
  5. HbA1c between 6.5% and 11.5%.
  6. Medical record contains HbA1c, lipid panel, BMI and blood pressure measures collected in the past three months.

Inclusion Criteria:(Routine Care group)

  1. 35 to 85 years of age, inclusive.
  2. Diagnosed with Type 2 Diabetes within the last 12 months.
  3. HbA1c between 6.5% and 11.5%.
  4. Medical record contains HbA1c, lipid panel, BMI and blood pressure measures collected in the past three months.

Exclusion Criteria (GEM group):

  1. Has Type 1 Diabetes
  2. Currently takes diabetes medication
  3. Currently takes medication that can interfere with metabolic control, such as prednisone
  4. Has a condition that precludes a low carbohydrate diet, such as gastroparesis
  5. Has a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
  6. Has kidney disease.
  7. Is receiving cancer treatment
  8. Cannot speak English
  9. Has blindness
  10. Is pregnant or anticipates becoming pregnant in the next 4 months
  11. Anticipates moving away within the next 4 months

Exclusion Criteria (Routine Care group): Individuals who met any of the following criteria in the first year after their T2D diagnosis will be excluded from the Routine Care group

  1. Took medication that can interfere with metabolic control, such as prednisone
  2. Had a condition that precludes a low carbohydrate diet, such as gastroparesis
  3. Had a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
  4. Had kidney disease.
  5. Was receiving cancer treatment
  6. Was pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GEM + CGM
A self-directed lifestyle intervention for controlling Type 2 Diabetes
Behavioral: GEM + CGM
Participants follow the GEM guidebook for 4 months (1 month of intervention and 3 months of maintenance) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM to provide feedback about activity and blood glucose. The GEM guidebook covers Routine choices, Recovering from blood glucose excursions, Reducing blood glucose excursions, and Maintenance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Treatment Effect (TTE)
Time Frame: Change from baseline TTE at 3 months post-intervention
Measures the effect of the intervention on HbA1c. The TTE factors out the confounding effects of diabetes medications on HbA1c by adjusting for each medication's HbA1c-lowering equivalent.
Change from baseline TTE at 3 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: Change from baseline blood glucose at 3 months post-intervention
CGM measurement of blood glucose time in range, time above 150 mg/dL and time above 180 mg/dL Higher time in range means better outcomes.Higher time above 150 and 180 mg/dL means worse outcomes.
Change from baseline blood glucose at 3 months post-intervention
Physical activity
Time Frame: Change from baseline physical activity at 3 months post-intervention
FitBit measurement of hours active, active minutes, and total steps. Higher activity means better outcomes.
Change from baseline physical activity at 3 months post-intervention
Food Choice Questionnaire: High Glycemic Load (HGL)
Time Frame: Change from baseline Food Choice Questionnaire HGL at 3 months post-intervention
Measures the servings of HGL foods eaten in a typical week. The scale ranges from 0 to no maximum. Higher scores mean worse outcomes.
Change from baseline Food Choice Questionnaire HGL at 3 months post-intervention
Food Choice Questionnaire: Low Glycemic Load (LGL)
Time Frame: Change from baseline Food Choice Questionnaire LGL at 3 months post-intervention
Measures the servings of LGL foods eaten in a typical week. The scale ranges from 0 to no maximum. Higher scores mean better outcomes.
Change from baseline Food Choice Questionnaire LGL at 3 months post-intervention
Patient Health Questionnaire (PHQ-8)
Time Frame: Change from baseline PHQ-8 at 3 months post-intervention
Measures depressive symptoms. The scale ranges from 0 to 24. Higher scores mean worse outcomes.
Change from baseline PHQ-8 at 3 months post-intervention
Diabetes Knowledge Scale
Time Frame: Change from baseline Diabetes Knowledge Scale at 3 months post-intervention
Measures diabetes-related knowledge. The scale ranges from 0 to 26. Higher scores mean better outcomes.
Change from baseline Diabetes Knowledge Scale at 3 months post-intervention
Diabetes Empowerment Scale
Time Frame: Change from baseline Diabetes Empowerment Scale at 3 months post-intervention
Measures the psychosocial self-efficacy of people with diabetes. The scale ranges from 0 to 40. Higher scores mean better outcomes.
Change from baseline Diabetes Empowerment Scale at 3 months post-intervention
Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)
Time Frame: Change from baseline Diabetes Distress Scale at 3 months post-intervention
Measures concerns about diabetes. Each subscale ranges from 5 to 30. Higher scores mean worse outcomes.
Change from baseline Diabetes Distress Scale at 3 months post-intervention
Treatment Optimization Scale
Time Frame: Change from baseline Treatment Optimization Scale at 3 months post-intervention
Generates user feedback about improving the intervention. The scale ranges from 43 to 215. Higher scores mean better outcomes.
Change from baseline Treatment Optimization Scale at 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Cox, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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