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

Primary Purpose

PreDiabetes, Obesity, Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abbott Freestyle Libre 2
Standard physical activity and nutritional counseling for prediabetes management
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring pediatrics, prediabetes, obesity

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's of AlabamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CGM + Traditional Counseling

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

CGM Acceptability
Caregiver and patient acceptability of CGM use
Progression of prediabetes
change in hemoglobin A1c

Secondary Outcome Measures

Insulin sensitivity
HOMA-IR, fasting c-peptide, fasting pro-insulin
Hyperlipidemia
LDL, triglyceride, HDL, total cholesterol measurements
Transaminitis
AST, ALT
Glycemic metrics
CGM data including: time in target range, time above target range, post-prandial glucose excursion

Full Information

First Posted
August 15, 2022
Last Updated
June 5, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05505565
Brief Title
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
Official Title
Continuous Glucose Monitors in the Management of Youth With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity, Insulin Resistance
Keywords
pediatrics, prediabetes, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, non-blinded, parallel, intervention vs control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGM + Traditional Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Abbott Freestyle Libre 2
Intervention Description
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
Intervention Type
Other
Intervention Name(s)
Standard physical activity and nutritional counseling for prediabetes management
Intervention Description
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.
Primary Outcome Measure Information:
Title
CGM Acceptability
Description
Caregiver and patient acceptability of CGM use
Time Frame
6 months
Title
Progression of prediabetes
Description
change in hemoglobin A1c
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Insulin sensitivity
Description
HOMA-IR, fasting c-peptide, fasting pro-insulin
Time Frame
6 months
Title
Hyperlipidemia
Description
LDL, triglyceride, HDL, total cholesterol measurements
Time Frame
6 months
Title
Transaminitis
Description
AST, ALT
Time Frame
6 months
Title
Glycemic metrics
Description
CGM data including: time in target range, time above target range, post-prandial glucose excursion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica A Schmitt, MD
Phone
2056385033
Email
jessicaschmitt@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ambika Ashraf, MD
Phone
2056389107
Email
AAshraf@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica A Schmitt, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica A Schmitt, MD
Phone
205-638-5033
Email
jessicaschmitt@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Ambika Ashraf, MD
Phone
2056389107
Email
AAshraf@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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