Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Not Applicable

Terminated

• Conditions: PreDiabetes; Weight Loss
• Interventions: Other: Dietitian; Device: CGM

• Registration Number: NCT03844646
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-12-18
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Results First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietitian only	Dietitian	Dietitian support only
CGM plus dietitian	CGM	Intermittent use of a continuous glucose monitor (CGM) plus dietitian support
CGM plus dietitian	Dietitian	Intermittent use of a continuous glucose monitor (CGM) plus dietitian support

Primary Outcome Measures

Name	Time	Method
Amount of Weight Lost (kg)	Baseline to end of study (3 months)	Weight lost during the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford; 🇺🇸 Stanford, California, United States