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Regular Insulin vs Rapid Insulin Delivered by V-Go | Clinical Trials | Clareo Health

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Regular Insulin vs Rapid Insulin Delivered by V-Go

Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes

NCT03495908•East Coast Institute for Research

View on ClinicalTrials.gov

Summary

The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 21 years at time of study enrollment
•2. Diagnosed with T2D for at least 6 months prior to screening
•3. Screening visit A1C ≥ 7.0% and ≤ 12.5%
•4. Prescribed a stable (less than 20% change in the past 30 days) of rapid acting U-100 insulin delivered via V-Go insulin delivery device
•5. Ability to read and understand English
•6. Willing to complete all study related activities
•7. Willing and able to understand and sign a written ICF indicating that they agree to participate and have been informed of all pertinent aspects of the study
•8. Must be willing to take and record 7 glucose measurements per time period (pre-morning meal (fasting), pre-midday meal, pre-evening meal, and 2-hours after the start of the morning, midday, and evening meals, and at bedtime) three times throughout the study (prior to Visit 2, 3, and 4).
•9. Completed a 7-point glucose profile prior to Visit 2
•10. Able (by insurance or financial means) to cover the initial investment and ongoing cost of the V-Go insulin delivery device, insulin (current rapid acting insulin or potential new regular human insulin), personal glucometer and supplies for the length of the study.

Exclusion Criteria

•1. Subject with confirmed Type 1 diabetes
•2. More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry
•3. History of hypoglycemia unawareness
•4. Require supplemental insulin in addition to V-Go therapy
•5. Woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. Women of childbearing potential are defined as any female who has experienced menarche and who it NOT permanently sterile of postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause.
•6. Woman who are lactating.
•7. Use of any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
•8. A recipient of a solid organ transplant
•9. Current use of U-100 RHI in V-Go within 90 days of screening
•10. Current use of U-500 RHI in V-Go within 90 days of screening
+2 more criteria

Locations (2)

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

East Coast Institute for Research, LLC

Macon, Georgia, United States

Key Dates

Start Date

April 9, 2018

Primary Completion Date

August 12, 2019

Completion Date

August 12, 2019

Last Updated

March 2, 2021

Enrollment

136

ACTUAL participants

Conditions

Type 2 DiabetesType 2 Diabetes Mellitus

Interventions

VGo

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

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NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Regular Insulin vs Rapid Insulin Delivered by V-Go

Inclusion Criteria

Exclusion Criteria

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