Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

January 12, 2023 updated by: Sun H Kim, Stanford University

Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight/obese (BMI 25-40 kg/m2)
  • Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)

Exclusion Criteria:

  • On glucose-lowering medications (e.g., metformin)
  • On weight-loss medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CGM plus dietitian
Intermittent use of a continuous glucose monitor (CGM) plus dietitian support
Device: CGM
Intermittent use of a continuous glucose monitor (CGM)
Other: Dietitian
Monthly meetings with a dietitian
OTHER: Dietitian only
Dietitian support only
Other: Dietitian
Monthly meetings with a dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Weight Lost (kg)
Time Frame: Baseline to end of study (3 months)
Weight lost during the study
Baseline to end of study (3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
Time Frame: Baseline to end of study (3 months)
Baseline to end of study (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Sun Kim, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49402
  • P30DK116074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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