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Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05505565
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).

Condition or Disease Intervention/Treatment Phase
  • Device: Abbott Freestyle Libre 2
  • Other: Standard physical activity and nutritional counseling for prediabetes management
 N/A

Detailed Description

The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.

There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, non-blinded, parallel, intervention vs control groupRandomized, non-blinded, parallel, intervention vs control group
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Continuous Glucose Monitors in the Management of Youth With Prediabetes
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CGM + Traditional Counseling

Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.

Device: Abbott Freestyle Libre 2
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.

Other: Standard physical activity and nutritional counseling for prediabetes management
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.
Active Comparator: Control

Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.

Other: Standard physical activity and nutritional counseling for prediabetes management
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.

Outcome Measures

Primary Outcome Measures

  1. CGM Acceptability [6 months]

    Caregiver and patient acceptability of CGM use

  2. Progression of prediabetes [6 months]

    change in hemoglobin A1c

Secondary Outcome Measures

  1. Insulin sensitivity [6 months]

    HOMA-IR, fasting c-peptide, fasting pro-insulin

  2. Hyperlipidemia [6 months]

    LDL, triglyceride, HDL, total cholesterol measurements

  3. Transaminitis [6 months]

    AST, ALT

  4. Glycemic metrics [6 months]

    CGM data including: time in target range, time above target range, post-prandial glucose excursion

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age 14 or older

  • English-speaking

  • stable metformin dose for 1 month prior to enrollment or no metformin use

  • baseline A1c of 5.7-6.4%

  • tanner stage 3 or above

  • BMI > = 85% for age

Exclusion Criteria:

  • BMI < 85% for age

  • chronic steroid use

  • diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes

  • current or history of malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's of Alabama Birmingham Alabama United States 35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jessica A Schmitt, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Schmitt, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05505565
Other Study ID Numbers:
  • IRB-300009480
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jessica Schmitt, Assistant Professor, University of Alabama at Birmingham
pediatrics
prediabetes
obesity
Additional relevant MeSH terms:
Insulin Resistance
Prediabetic State
Glucose Intolerance

Study Results

No Results Posted as of Aug 17, 2022