Diabetes Mellitus, Type 1
Conditions
Brief summary
Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®
Interventions
DEVICEMiniMed® Pro-set®
Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.
DEVICEMiniMed® Quick-set®
Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia | 6 hours from time of insertion |
Secondary
| Measure | Time frame |
|---|---|
| Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl. | 6 hours from time of insertion |
| Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl. | 72 hours of set wear that occurs at 6 hours or later after insertion |
| Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion. | 60 hours post insertion |
| Compare Pro-set® vs. Quick- set® for duration of wear | % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours) |
Outcome results
None listed