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Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Primary Purpose

Weight Loss, PreDiabetes

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CGM

Dietitian

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CGM plus dietitian

Dietitian only

Arm Description

Intermittent use of a continuous glucose monitor (CGM) plus dietitian support

Dietitian support only

Outcomes

Primary Outcome Measures

Amount of Weight Lost (kg)

Weight lost during the study

Secondary Outcome Measures

Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More

Full Information

NCT ID

NCT03844646

First Posted

February 14, 2019

Last Updated

January 12, 2023

Sponsor

Stanford University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03844646

Brief Title

Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID-19

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss, PreDiabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CGM plus dietitian

Arm Type

Experimental

Arm Description

Intermittent use of a continuous glucose monitor (CGM) plus dietitian support

Arm Title

Dietitian only

Arm Type

Other

Arm Description

Dietitian support only

Intervention Type

Device

Intervention Name(s)

CGM

Intervention Description

Intermittent use of a continuous glucose monitor (CGM)

Intervention Type

Other

Intervention Name(s)

Dietitian

Intervention Description

Monthly meetings with a dietitian

Primary Outcome Measure Information:

Title

Amount of Weight Lost (kg)

Description

Weight lost during the study

Time Frame

Baseline to end of study (3 months)

Secondary Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun Kim, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

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