N/A
Completed N=60
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System
Source: ClinicalTrials.gov NCT01111370 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: the Proportion of G4 CGM System in Agreement With the Reference Standard — 80 %20/20
Summary
The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.
Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study (PTL-900360) meeting the above criteria will be compared to the proportion of such points observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL 300012).
Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Proportion of G4 CGM System in Agreement With the Reference Standard |
80 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older;
- Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
- Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
- Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration;
- Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes);
- Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
- Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
- Able to speak, read, and write English.
Exclusion Criteria
- Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Subjects who have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
- Have a hematocrit that is less than 30%, or greater than 55%;
- Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
Data sourced from ClinicalTrials.gov (NCT01111370). 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.