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Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

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ClinicalTrials.gov Identifier: NCT03844646
Recruitment Status : Suspended (COVID-19)
First Posted : February 18, 2019
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sun H Kim, 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.

Condition or disease Intervention/treatment Phase
Weight Loss PreDiabetes Device: CGM Other: Dietitian Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CGM plus dietitian
Intermittent use of a continuous glucose monitor (CGM) plus dietitian support
Device: CGM
Intermittent use of a continuous glucose monitor (CGM)

Other: Dietitian
Monthly meetings with a dietitian

Dietitian only
Dietitian support only
Other: Dietitian
Monthly meetings with a dietitian




Primary Outcome Measures :
  1. Amount of weight lost (kg) [ Time Frame: Baseline to end of study (3 months) ]
    Weight lost during the study


Secondary Outcome Measures :
  1. Change in moderate physical activity [ Time Frame: Baseline to end of study (3 months) ]
    Change in number of minutes of moderate physical activity (brisk walking)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844646


Locations
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United States, California
Stanford
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sun Kim, MD Stanford University
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Responsible Party: Sun H Kim, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03844646    
Other Study ID Numbers: 49402
P30DK116074 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Body Weight
Weight Loss
Body Weight Changes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia