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Completed

NCT Number: NCT05523362

Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes

The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.

During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.

All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes of any duration
  • Hb A1c ≥ 7% (no upper limit)
  • BMI ≥ 30 kg/m2
  • Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
  • Access to a smartphone device

Exclusion criteria

  • Any insulin use in the past 3 months
  • Planned use of insulin in the next 6 months
  • Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
  • Current use of a weight loss medication
  • Unable or uncomfortable with wearing a CGM device

Treatment and study plan

Dexcom continuous glucose monitor

Device

The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

Primary outcomes

  1. Change in Average Glucose Levels as Measured by Continuous Glucose Monitor

    Time frame: 0, 30, 60, 90 days

    Average glucose on CGM

  2. Change in Time in Range as Measured by Continuous Glucose Monitor

    Time frame: 0, 30, 60, 90 days

    Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.

  3. Change in Glucose Variability as Measured by Continuous Glucose Monitor

    Time frame: 0, 30, 60, 90 days

    Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.

Secondary outcomes

  1. Change in Hemoglobin A1c From Blood Test

    Time frame: 0 and 90 days

    Glycosylated hemoglobin

  2. Change in Total Cholesterol From Blood Test

    Time frame: 0 and 90 days

    Total cholesterol

  3. Change in Low Density Lipoprotein Cholesterol From Blood Test

    Time frame: 0 and 90 days

    LDL-C

  4. Change in High Density Lipoprotein Cholesterol From Blood Test

    Time frame: 0 and 90 days

    HDL-C

  5. Change in Triglycerides From Blood Test

    Time frame: 0 and 90 days

    Triglycerides

  6. Change in Body Mass Index From Height and Weight

    Time frame: 0 and 90 days

    BMI

  7. Change in Systolic Blood Pressure From Automated Cuff

    Time frame: 0 and 90 days

    Systolic blood pressure

  8. Change in Diastolic Blood Pressure From Automated Cuff

    Time frame: 0 and 90 days

    Diastolic blood pressure

  9. Picture Your Plate Dietary Assessment Questionnaire

    Time frame: 0, 90 days

    Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.

  10. Type 2 Diabetes Distress Screening Scale (T2-DDAS)

    Time frame: 0, 90 days

    The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale:

    Mean score < 2.0 indicate little or no distress.

    Mean score between 2.0 and 2.9 indicate moderate distress.

    Mean score > 3.0 indicate high distress

  11. International Physical Activity Questionnaire (IPAQ)

    Time frame: 0, 90 days

    The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.

    Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.

  12. Glucose Monitoring Satisfaction Survey

    Time frame: 90 days

    The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.

Sponsors and collaborators

Lead sponsor

Ian J. Neeland, MD

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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