Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

NCT ID: NCT04436822

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2022-04-12

Brief Summary

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Detailed Description

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

This is a multi-center study.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects with diabetes wearing DS5

Subjects wearing DS5 over 7 days and participating in FSTs.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type: DEVICE

CGM and frequent sample testing

Interventions

Continuous Glucose Monitoring

CGM and frequent sample testing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Individual is 2 - 80 years of age at time of enrollment.

2. Subject has a clinical diagnosis of type 1 or type 2 diabetes:

1. If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.

2. If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.

3. If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.

4. Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.

Exclusion Criteria

1. Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).

3. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)

4. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.

5. Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.

6. Subject is female and plans to become pregnant during the course of the study.

7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.

8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.

9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.

10. Subject has a history of a seizure disorder.

11. Subject has central nervous system or cardiac disorder resulting in syncope.

12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease

13. If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).

14. Subject has a history of adrenal insufficiency.

15. Subject is a member of the research staff involved with the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AMCR Institute

Escondido, California, United States

Sansum Diabetes Research Institute

Santa Barbara, California, United States

SoCal Diabetes

Torrance, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

University of South Florida

Tampa, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, United States

Texas Diabetes & Endocrinology

Austin, Texas, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Nanjing First Hospital

Nanjing, Jiangsu, China

Dalian Municiple Central Hospital

Dalian, Liaoning, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

United States; China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP330

Identifier Type: -

Identifier Source: org_study_id