N/A
Completed N=24
New Generation Enlite Accuracy Study
Source: ClinicalTrials.gov NCT02423798 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Sensor Accuracy — 9.13 percentage
Summary
The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components.
To evaluate the accuracy and performance of the new generation Enlite sensor. This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial.
The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensor Accuracy |
9.13 | — |
| PRIMARY Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values |
100.0 | — |
| PRIMARY Sensor Survival |
130.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has signed the informed consent form prior to screening
- Age 18-74 years (both inclusive)
- Subject has been diagnosed with T1DM
- Subject is current insulin pump user for at least 3 months
- HbA1c 9.5%
- With the exception of T1DM, the subject is considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and biochemical investigations as judged by the Investigator
Exclusion Criteria
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence, vasectomized partner)
- Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
- Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
- Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 30 days
- Subject known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice).
- Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen according to locally used diagnostic testing
- Significant history of alcoholism or drug/chemical abuse as per investigator's judgment, current regular alcohol consumption of more than 1 unit per day for women and more than 2 units per day for men [1 unit of alcohol equals 1 beer (330 mL), 1 glass of wine (120 mL), or 1 glass of spirits (40 mL)], or a positive result in the urine drug/alcohol screen at the screening visit
Data sourced from ClinicalTrials.gov (NCT02423798). 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.