Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

NCT03844646 | Terminated Results FDA Device

• 2 other identifiers: 49402P30DK116074
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Amount of Weight Lost (kg)

  Weight lost during the study

  Baseline to end of study (3 months)

Secondary Outcomes (1)

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

  Baseline to end of study (3 months)

Study Arms (2)

CGM plus dietitian

EXPERIMENTAL

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

Device: CGM; Other: Dietitian

Dietitian only

OTHER

Dietitian support only

Other: Dietitian

Interventions

CGM DEVICE

Intermittent use of a continuous glucose monitor (CGM)

CGM plus dietitian

Dietitian OTHER

Monthly meetings with a dietitian

CGM plus dietitian; Dietitian only

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Weight Loss; Prediabetic State

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

This study did not achieve its planned sample size and is underpowered.

Results Point of Contact

• Title: Sun H. Kim, MD, MS
• Organization: Stanford University

sunhkim@stanford.edu

650-723-8284

Study Officials

• Sun Kim, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)