NCT03242005撤回不适用
The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
研究概览
简要总结
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®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)
- •MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)
- •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
排除标准
- •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
研究组 & 干预措施
Pro-set® vs. Quick-set®
Experimental
Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design.
干预措施: MiniMed® Pro-set® (Device)
Pro-set® vs. Quick-set®
Experimental
Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design.
干预措施: MiniMed® Quick-set® (Device)
结局指标
主要结局
Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
时间窗: 6 hours from time of insertion
次要结局
- 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 duration of wear(% reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours))
- 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)
研究者
相似试验
Unknown
不适用
Comparison of CSII and MDI in Pediatric Patients With Type 1 DiabetesType 1 DiabetesNCT05201846Seoul National University Hospital66
已完成
不适用
Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargineDiabetes mellitus type oneNutritional, Metabolic, EndocrineDiabetes mellitusISRCTN37153662Disetronic Medical Systems AG (Switzerland)50
终止
4 期
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 DiabetesPatient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus StrategyNCT02048189Centre Hospitalier Universitaire Dijon14
终止
不适用
Comparison of Insulin Pump and MDI for Pregestational Diabetes During PregnancyPregnancyType 2 DiabetesType 1 DiabetesNCT02064023University of British Columbia2
已完成
不适用
Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical PracticeType 1 Diabetes MellitusNCT03793283Castilla-La Mancha Health Service90