Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

NCT ID: NCT03844646

Last Updated: 2023-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Weight Loss PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM plus dietitian

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

Group Type EXPERIMENTAL

CGM

Intervention Type DEVICE

Intermittent use of a continuous glucose monitor (CGM)

Dietitian

Intervention Type OTHER

Monthly meetings with a dietitian

Dietitian only

Dietitian support only

Group Type OTHER

Dietitian

Intervention Type OTHER

Monthly meetings with a dietitian

Interventions

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CGM

Intermittent use of a continuous glucose monitor (CGM)

Intervention Type DEVICE

Dietitian

Monthly meetings with a dietitian

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sun H Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P30DK116074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

49402

Identifier Type: -

Identifier Source: org_study_id

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