Clinical trial NCT04632849: The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: West Virginia University
First posted: 2020-11-17
Enrollment: 17
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the GEM intervention.
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Treatment Effect (TTE)
timeFrame: Change from baseline TTE at 3 months post-intervention
Secondary outcomes:
measure: Blood glucose
timeFrame: Change from baseline blood glucose at 3 months post-intervention
measure: Physical activity
timeFrame: Change from baseline physical activity at 3 months post-intervention
measure: Food Choice Questionnaire: High Glycemic Load (HGL)
timeFrame: Change from baseline Food Choice Questionnaire HGL at 3 months post-intervention
measure: Food Choice Questionnaire: Low Glycemic Load (LGL)
timeFrame: Change from baseline Food Choice Questionnaire LGL at 3 months post-intervention
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Change from baseline PHQ-8 at 3 months post-intervention
measure: Diabetes Knowledge Scale
timeFrame: Change from baseline Diabetes Knowledge Scale at 3 months post-intervention
measure: Diabetes Empowerment Scale
timeFrame: Change from baseline Diabetes Empowerment Scale at 3 months post-intervention
measure: Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)
timeFrame: Change from baseline Diabetes Distress Scale at 3 months post-intervention
measure: Treatment Optimization Scale
timeFrame: Change from baseline Treatment Optimization Scale at 3 months post-intervention
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Daniel J Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.