A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China

NCT03710083 | Completed Results FDA Device

• 1 other identifier: CIP320
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.

Conditions

Diabetes Mellitus

Keywords

Diabetes Type I Type II

Outcome Measures

Primary Outcomes (4)

• Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI

  Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days.

  168 Hours

• Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B

  A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B.

  168 Hours

• Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B

  A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.

  168 Hours

• Mean Absolute Relative Difference (MARD)

  Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple FST days were pooled together for reporting purpose.

  168 Hours

Study Arms (1)

Study arm

EXPERIMENTAL

Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7).

Device: Guardian™ Sensor (3)

Interventions

Guardian™ Sensor (3) DEVICE

Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.

Study arm

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 14 - 75 years of age at time of screening
• Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Subject has adequate venous access as assessed by investigator or appropriate staff
• Subject is willing to follow the study procedures and willing to come to study visits

You may not qualify if:

• Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by qualified individual.
• Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• 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
• Subject is female and has a positive pregnancy screening test
• Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
• Subject is female and plans to become pregnant during the course of the study
• Subject has a hematocrit (Hct) lower than the normal reference range
• Subject may not be on the research staff of those performing this study

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (3)

The Seventh Medical Center of PLA General Hospital

Beijing, 100700, China

Location

Sir Run Run Shaw Hospital

Hangzhou, 310016, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Vivian Chen, Statistician
• Organization: Medtronic Minimed

vivian.chen@medtronic.com

8185763309

Study Officials

• Jian Zhou, MD

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaofeng Lv, MD

  Seventh Medical Center of PLA Army General Hospital

  PRINCIPAL INVESTIGATOR

• Hong Li, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: February 28, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: September 9, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-08

Locations

CN (3)