Last reviewed · How we verify
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
NA trial testing Guardian™ Sensor (3) in Diabetes Mellitus in 72 participants. Completed in 25 July 2019.
| Lead sponsor | Medtronic MiniMed, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 28 February 2019 |
| Primary completion | 25 July 2019 |
| Estimated completion | 25 July 2019 |
| Sites | 3 locations across China |
Medtronic MiniMed, Inc.
Adults 14 to 75, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Study Arm | 93.2 | 92.1 – 94.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Study Arm | 100 | 100 – 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Study Arm | 99.8 | 99.5 – 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Study Arm | 8.11 | ± 4.02 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03710083.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing