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Diabetes Mellitus, Type 2NCT04632849

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

A study testing GEM + CGM in people with Diabetes Mellitus, Type 2, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
GEM + CGM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 1 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Has Type 1 Diabetes
  • Currently takes diabetes medication
  • Currently takes medication that can interfere with metabolic control, such as prednisone
  • Has a condition that precludes a low carbohydrate diet, such as gastroparesis
  • Has a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
  • Has kidney disease.
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  • Is receiving cancer treatment
  • Cannot speak English
  • Has blindness
  • Is pregnant or anticipates becoming pregnant in the next 4 months
  • 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
  • Took medication that can interfere with metabolic control, such as prednisone
  • Had a condition that precludes a low carbohydrate diet, such as gastroparesis
  • Had a physical or medical condition that precludes walking 120 steps per minute, for 10 minutes or longer
  • Had kidney disease.
  • Was receiving cancer treatment
  • Was pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
GEM + CGM
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEM + CGMBehavioural

    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.

Study groups in NCT04632849
Study groupRoleWhat they receive
GEM + CGMExperimentalA self-directed lifestyle intervention for controlling Type 2 Diabetes
Receives: Behavioral: GEM + CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Treatment Effect (TTE)

    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.

    Measured: Change from baseline TTE at 3 months post-intervention

Secondary outcomes (9)

  1. Blood glucose

    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.

    Measured: Change from baseline blood glucose at 3 months post-intervention

  2. Physical activity

    FitBit measurement of hours active, active minutes, and total steps. Higher activity means better outcomes.

    Measured: Change from baseline physical activity at 3 months post-intervention

  3. Food Choice Questionnaire: High Glycemic Load (HGL)

    Measures the servings of HGL foods eaten in a typical week. The scale ranges from 0 to no maximum. Higher scores mean worse outcomes.

    Measured: Change from baseline Food Choice Questionnaire HGL at 3 months post-intervention

  4. Food Choice Questionnaire: Low Glycemic Load (LGL)

    Measures the servings of LGL foods eaten in a typical week. The scale ranges from 0 to no maximum. Higher scores mean better outcomes.

    Measured: Change from baseline Food Choice Questionnaire LGL at 3 months post-intervention

  5. Patient Health Questionnaire (PHQ-8)

    Measures depressive symptoms. The scale ranges from 0 to 24. Higher scores mean worse outcomes.

    Measured: Change from baseline PHQ-8 at 3 months post-intervention

  6. Diabetes Knowledge Scale

    Measures diabetes-related knowledge. The scale ranges from 0 to 26. Higher scores mean better outcomes.

    Measured: Change from baseline Diabetes Knowledge Scale at 3 months post-intervention

  7. Diabetes Empowerment Scale

    Measures the psychosocial self-efficacy of people with diabetes. The scale ranges from 0 to 40. Higher scores mean better outcomes.

    Measured: Change from baseline Diabetes Empowerment Scale at 3 months post-intervention

  8. Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)

    Measures concerns about diabetes. Each subscale ranges from 5 to 30. Higher scores mean worse outcomes.

    Measured: Change from baseline Diabetes Distress Scale at 3 months post-intervention

  9. Treatment Optimization Scale

    Generates user feedback about improving the intervention. The scale ranges from 43 to 215. Higher scores mean better outcomes.

    Measured: Change from baseline Treatment Optimization Scale at 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion1 Aug 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive the GEM intervention.
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632849
Sponsor's protocol ID
22635
Status last verified
Oct 2021
First submitted
3 Nov 2020
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cox DJ, Banton T, Moncrief M, Conaway M, Diamond A, McCall AL. Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial. J Endocr Soc. 2020 Aug 18;4(11):bvaa118. doi: 10.1210/jendso/bvaa118. eCollection 2020 Nov 1.

    PubMed 33094208

Questions about this trial

What is this clinical trial studying?

A study testing GEM + CGM in people with Diabetes Mellitus, Type 2, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Treatment Effect (TTE) (time frame: Change from baseline TTE at 3 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04632849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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