N/A
Completed N=66
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
Source: ClinicalTrials.gov NCT03710083 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI — 93.2 percentage of paired readings
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI |
93.2 | — |
| PRIMARY Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B |
100 | — |
| PRIMARY Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B |
99.8 | — |
| PRIMARY Mean Absolute Relative Difference (MARD) |
8.11 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03710083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.