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NCT03844646 Clinical Trial

Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03844646
Other study ID # 49402
Secondary ID P30DK116074
Status Terminated
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2021

Study information
Verified date January 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CGM
Intermittent use of a continuous glucose monitor (CGM)
Other:
• Dietitian
Monthly meetings with a dietitian

Locations
Country Name City State
United States Stanford Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of Weight Lost (kg) Weight lost during the study Baseline to end of study (3 months)
Secondary Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More Baseline to end of study (3 months)
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