Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03242005
Eligibility Criteria:
Inclusion Criteria:
* Must be between 13 and 70 years of age (inclusive)
* Must have been previously diagnosed with type 1 diabetes mellitus
* Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software.
1. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)
2. MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)
3. MiniMed 630G System
* Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so
* Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio)
* If instructed, must be willing to insert all assigned infusion sets with a mechanical inserter
* Must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle)
* Must agree to continue using current Medtronic Enlite CGM throughout the study
* Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink Therapy Management Software (requires subject CareLink logon ID and password)
* In stable health status with no acute or significant illness, in the opinion of the investigator or designee
* Able to read, write and follow instructions in English
* Able and willing to provide informed consent
* Able and willing to comply with study procedures
Exclusion Criteria:
* Pregnant (self-attestation) or nursing
* Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go
* Currently using the Medtronic Model 670G pump and associated CGM
* Current or past participation in previous BD Study DBC-16SCARL21
* History of bleeding disorder or easy bruising.
* Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted).
* Known blood borne infections.
* History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis).
* Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site.
* Physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported)
* Currently participating in any other clinical investigation that conflicts with this study
* Employed by, or currently serving as a contractor or consultant to BD, Medtronic or study site
* Any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
70 Years
Study:
NCT03242005
Study Brief:
Protocol Section:
NCT03242005