Type 2 DiabetesNCT05720377
Evaluation of Exercise Application Technology in Adolescents
A study testing continuous glucose monitor (Freestyle Libre in people with Type 2 Diabetes and PreDiabetes, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes, Obesity
- What is being tested?
- continuous glucose monitor (Freestyle Libre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2027
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI > 95th percentile
- A1c> 6.5%
- Age 14-17 (2 years post-menarchal)
- Age 14-17 (2 years post-menarchal)
- A1c 5.7-6.4%
- Age 14-17 (2 years post-menarchal)
- A1c 5.7-6.4%
Who cannot join
- BMI <95th percentile
- Specific obesity syndrome
- Inability to participate in exercise workouts
About this study
Official title: Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents
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.
Read the detailed description
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)
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Being tested
- continuous glucose monitor (Freestyle Libre
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitor (Freestyle LibreDevice
Also called Contact by health care provider
15 minute phone interview by health care provider to assess health goals set at clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Obese, receives access to exercise phone application | Experimental | obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor Receives: Device: continuous glucose monitor (Freestyle Libre |
| Obese, no intervention | No intervention | obese, receives continuous glucose monitor |
| Prediabetes, receives access to exercise phone application | Experimental | prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor Receives: Device: continuous glucose monitor (Freestyle Libre |
| Prediabetes, no intervention | No intervention | prediabetes, receives continuous glucose monitor |
| Type 2 diabetes, receives access to exercise phone application | Experimental | prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor Receives: Device: continuous glucose monitor (Freestyle Libre |
| Type 2 diabetes, no intervention | No intervention | Type 2 diabetes, receives continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin fold thickness
reliable estimate of subcutaneous fat at various sites of the body
Measured: baseline
skin fold measurement
reliable estimate of subcutaneous fat at various sites of the body
Measured: 3 month
skin fold measurement
reliable estimate of subcutaneous fat at various sites of the body
Measured: 6 month
Body mass index
measure of body fat based on height and weight
Measured: baseline
Body mass index
measure of body fat based on height and weight
Measured: 3 month
Body Mass Index
measure of body fat based on height and weight
Measured: 6 month
Secondary outcomes (6)
TNF-alpha
inflammatory marker in the blood
Measured: baseline
TNF-alpha
inflammatory marker in the blood
Measured: 3 months
TNF-alpha
inflammatory marker in the blood
Measured: 6 months
IL-6
inflammatory marker in the blood
Measured: Baseline
IL-6
inflammatory marker in the blood
Measured: 3 months
IL-6
inflammatory marker in the blood
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- longitudinal
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christy Foster, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720377
- Sponsor's protocol ID
- IRB-300007608
- Other IDs
- UAB
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents
- ClinicalTrials.gov ID
- NCT05720377
- Acronym / sponsor ID
- IRB-300007608
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- longitudinal
| Arm | Type | Receives |
|---|---|---|
| Obese, receives access to exercise phone application | Experimental | Device: continuous glucose monitor (Freestyle Libreobese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor |
| Obese, no intervention | No intervention | –obese, receives continuous glucose monitor |
| Prediabetes, receives access to exercise phone application | Experimental | Device: continuous glucose monitor (Freestyle Libreprediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor |
| Prediabetes, no intervention | No intervention | –prediabetes, receives continuous glucose monitor |
| Type 2 diabetes, receives access to exercise phone application | Experimental | Device: continuous glucose monitor (Freestyle Libreprediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor |
| Type 2 diabetes, no intervention | No intervention | –Type 2 diabetes, receives continuous glucose monitor |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- BMI > 95th percentile
- A1c> 6.5%
- Age 14-17 (2 years post-menarchal)
- Age 14-17 (2 years post-menarchal)
- A1c 5.7-6.4%
Key exclusion criteria (3 listed)
- BMI <95th percentile
- Specific obesity syndrome
- Inability to participate in exercise workouts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose monitor (Freestyle LibreAlso: Contact by health care provider15 minute phone interview by health care provider to assess health goals set at clinic visits. | Device | Obese, receives access to exercise phone application, Prediabetes, receives access to exercise phone application, Type 2 diabetes, receives access to exercise phone application |
Primary outcome
skin fold thickness
Time frame: baseline
reliable estimate of subcutaneous fat at various sites of the body
skin fold measurement
Time frame: 3 month
reliable estimate of subcutaneous fat at various sites of the body
skin fold measurement
Time frame: 6 month
reliable estimate of subcutaneous fat at various sites of the body
Body mass index
Time frame: baseline
measure of body fat based on height and weight
Body mass index
Time frame: 3 month
measure of body fat based on height and weight
Body Mass Index
Time frame: 6 month
measure of body fat based on height and weight
6 secondary outcomes
TNF-alpha
Time frame: baseline
TNF-alpha
Time frame: 3 months
TNF-alpha
Time frame: 6 months
IL-6
Time frame: Baseline
IL-6
Time frame: 3 months
IL-6
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing continuous glucose monitor (Freestyle Libre in people with Type 2 Diabetes and PreDiabetes, run by University of Alabama at Birmingham.
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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
skin fold thickness (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.