An interventional study of continuous glucose monitor (Freestyle Libre in Type 2 Diabetes, PreDiabetes and Obesity, sponsored by University of Alabama at Birmingham. Withdrawn. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.
Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes.
Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw.
Intervention Group
Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week.
Meeting with nutrition at Baseline visit
Continuous glucose monitor provided (plan to wear for 14 days during each month)
Non-Intervention Group
Meeting with nutrition at Baseline visit
Continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Inclusion Criteria for Type 2 diabetes arm
Inclusion for Prediabetes Arm
Inclusion for Obesity Arm
Exclusion Criteria for all arms
obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor
Device: continuous glucose monitor (Freestyle Libre
obese, receives continuous glucose monitor
prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor
Device: continuous glucose monitor (Freestyle Libre
prediabetes, receives continuous glucose monitor
prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor
Device: continuous glucose monitor (Freestyle Libre
Type 2 diabetes, receives continuous glucose monitor
15 minute phone interview by health care provider to assess health goals set at clinic visits.
Also known as: Contact by health care provider
skin fold thickness
reliable estimate of subcutaneous fat at various sites of the body
Time frame: baseline
skin fold measurement
reliable estimate of subcutaneous fat at various sites of the body
Time frame: 3 month
skin fold measurement
reliable estimate of subcutaneous fat at various sites of the body
Time frame: 6 month
Body mass index
measure of body fat based on height and weight
Time frame: baseline
Body mass index
measure of body fat based on height and weight
Time frame: 3 month
Body Mass Index
measure of body fat based on height and weight
Time frame: 6 month
TNF-alpha
inflammatory marker in the blood
Time frame: baseline
TNF-alpha
inflammatory marker in the blood
Time frame: 3 months
TNF-alpha
inflammatory marker in the blood
Time frame: 6 months
IL-6
inflammatory marker in the blood
Time frame: Baseline
IL-6
inflammatory marker in the blood
Time frame: 3 months
IL-6
inflammatory marker in the blood
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham