An observational study in Pre Diabetes, sponsored by University of Arizona. Not yet recruiting. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Arizona · Observational
Prediabetes is a condition wherein blood sugar levels are elevated but not sufficiently high enough to diagnose type 2 diabetes mellitus (T2D). Prediabetes is a critical risk factor for the development of T2D in pediatric populations. This progression can occur over a short period of time, limiting the efficacy and impact of existing interventions and recommendations targeting this population. There is growing evidence on the use of continuous glucose monitors (CGMs) in adult prediabetic populations to prevent the development of T2D, though this intervention has not been thoroughly investigated in pediatric populations.
The investigators are proposing a pilot study of 25 prediabetic adolescents enrolled in a 20-week study. For the initial 10 weeks of the study, the participants will go without CGMs and undergo clinically recommended education on their condition as standard of care. In the 10 weeks following, participants will be given a CGM to wear and instructions on its use. Surveys will be issued to all participants over the entirety of the study to follow behaviors surrounding food and physical activity.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 25 is below the median of 218 across 109 observational studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Sudy population includes patients seen at Banner Hospital University Medical Center, Tucson.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least 13 years of age
Diagnosed prediabetes, defined as any of the following:
Exclusion Criteria:
Previous diagnosis of Prader Willi Syndrome
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: FitBit and continuous glucose monitoring
The purpose of this pilot study is to evaluate the effectiveness of CGMs in assisting prediabetic adolescents to make appropriate lifestyle changes aimed at preventing the development of T2D. The investigators hypothesize that the use of CGMs over 10 weeks will result in beneficial lifestyle changes, relative to a period without CGM. The investigators will evaluate beneficial lifestyle changes by following eating habits, physical activity levels, and biometric measurements
Behavioral Changes as measured by questionnaires
Participants will complete a standardized questionnaire assessing dietary intake and physical activity every two weeks throughout the study period. Responses will be recorded using Likert-scale measures. Questionnaire results will be compared across study phases, including before and after continuous glucose monitor (CGM) use, to evaluate changes over time.
Time frame: 20 weeks
Physical Activity
We will track physical activity as steps measured by the FitBit.
Time frame: From enrollment to the end of the study at 20 weeks
Height, weight and BMI
We will measure height (m), weight (kg) and BMI (kg/m2)
Time frame: From enrollment to the end of the study at 20 weeks
Glycemic patterns
Glycemic patterns will be evaluated using continuous glucose monitor (CGM) data. We will measure area under the curve (AUC).
Time frame: 10-20 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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