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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436822
• Other study ID #: CIP330
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: April 12, 2022

Study information

• Verified date: May 2023
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring
CGM and frequent sample testing

Locations

Country	Name	City	State
China	Dalian Municiple Central Hospital	Dalian	Liaoning
China	The Children's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Barbara Davis Center for Diabetes	Aurora	Colorado
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia
United States	AMCR Institute	Escondido	California
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	University of South Florida	Tampa	Florida
United States	SoCal Diabetes	Torrance	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Readings Within 20% Agreement	Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.	7 days (170 hours)