Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966911
• Other study ID #: CIP324
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: May 13, 2020

Study information

• Verified date: May 2021
• 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 Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Description:

The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• 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. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

3. 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 ratio. Subjects without ratios may participate under observation only

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) 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 (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks

4. Subject is female and has a positive pregnancy screening test

5. Female of child bearing age and who is sexually active should be excluded if she 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. Subject has a hematocrit (Hct) lower than the 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
• Type2 Diabetes Mellitus

Intervention

Device:
• Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Continuous Glucose Monitoring and frequent sample testing

Locations

Country	Name	City	State
United States	Barbara Davis Center - Adults	Aurora	Colorado
United States	Barbara Davis Center for Childhood Diabetes (Pediatric)	Aurora	Colorado
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	AM Diabetes & Endocrinology Center	Bartlett	Tennessee
United States	University of Virgina	Charlottesville	Virginia
United States	IDERC	Des Moines	Iowa
United States	AMCR Institue	Escondido	California
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	Rainer Clinical Research Center	Renton	Washington
United States	Mayo Clinic (Rochester MN)	Rochester	Minnesota
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	Walnut Creek	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

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 if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.	7 days (170 hours)