There are three updates for the CONCEPTT trial. How they affect your site is dependent on whether your site is in Canada or an International site.
1) EnLite Sensor Licensing in Canada (Canada)
The Medtronic EnLite Sensor was licensed for use in Canada, effective February 15, 2013. You may have submitted an investigational testing authorization (ITA) from Health Canada with your REB package. Now that the EnLite Sensor is licensed, it does not require Health Canada authorization for use in this trial. We have since emailed the license to all Canadian sites for submission to their REBs. Please email us if you require another copy.
2) Medtronic Disclosure Statement (Canada)
All Canadian sites must include a statement on confidentiality in their consent forms for use of the iPro, as patient’s blood sugar values will be uploaded to Medtronic’s remote data network (Medtronic CareLink® iPro network). Sample language was developed by the CONCEPTT Team which was forwarded to all Canadian sites for submission to their REBs. Please email if you have further questions.
3) Biorepository Samples for Pre-Pregnant patients (All Sites)
CCTN informed us that the biorepository samples for pre-pregnant patients will not be collected for the CONCEPTT trial. We are currently updating the protocol to reflect this change, and request you to remove any reference to biorepository samples being collected from pre-pregnant patients in your informed consent forms. We will continue to collect biorepository blood samples from pre-pregnant patients who become pregnant, with their explicit consent. Please ensure that your informed consent forms reflect this change and have been approved by your REB.
As you prepare your REB packages for submission, please feel free to contact us with any questions or if you need assistance. We are happy to assist you.
The CONCEPTT Team