NCT05720377

Brief 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. 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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
20mo left

Started Feb 2024

Longer than P75 for not_applicable type-2-diabetes

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Feb 2024Dec 2027

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

May 12, 2026

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

January 31, 2023

Last Update Submit

May 11, 2026

Conditions

Type 2 DiabetesPreDiabetesObesity

Outcome Measures

Primary Outcomes (6)

  • skin fold thickness

    reliable estimate of subcutaneous fat at various sites of the body

    baseline

  • skin fold measurement

    reliable estimate of subcutaneous fat at various sites of the body

    3 month

  • skin fold measurement

    reliable estimate of subcutaneous fat at various sites of the body

    6 month

  • Body mass index

    measure of body fat based on height and weight

    baseline

  • Body mass index

    measure of body fat based on height and weight

    3 month

  • Body Mass Index

    measure of body fat based on height and weight

    6 month

Secondary Outcomes (6)

  • TNF-alpha

    baseline

  • TNF-alpha

    3 months

  • TNF-alpha

    6 months

  • IL-6

    Baseline

  • IL-6

    3 months

  • +1 more secondary outcomes

Study Arms (6)

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

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

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

Device: continuous glucose monitor (Freestyle Libre

Type 2 diabetes, no intervention

NO INTERVENTION

Type 2 diabetes, receives continuous glucose monitor

Interventions

continuous glucose monitor (Freestyle LibreDEVICE

15 minute phone interview by health care provider to assess health goals set at clinic visits.

Also known as: Contact by health care provider
Obese, receives access to exercise phone applicationPrediabetes, receives access to exercise phone applicationType 2 diabetes, receives access to exercise phone application

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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%

You may not qualify if:

  • BMI \<95th percentile
  • Specific obesity syndrome
  • Inability to participate in exercise workouts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: longitudinal
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

May 12, 2026

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share