Clinical trial NCT01773668: Feasibility Study - Integrated Sensor and Infusion Set. Trial III
Official title: FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Medtronic Diabetes R&D Denmark
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.


Eligibility criteria: Inclusion Criteria:

* Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
* Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
* Subject has one or more established insulin carbohydrate ratio.
* Subject has one or more established insulin correction ratio.
* Subject is a high bolus user (\>10 units/meal) for at least one meal a day.
* Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has been using insulin for more than one year.
* Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
* Subject is willing to perform frequent SMBGs during Visits 3 and 4.
* Subject is in good general health without other acute or chronic illnesses.

Exclusion Criteria:

* Vulnerable population will not be included in the study
* Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
* Subject plans to become pregnant during the course of the study.
* 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 or device placement (e.g. psoriasis, rash, Staphylococcus infection).
* The subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months.
* The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data.
* The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.

Primary outcomes:
measure: Performance data
timeFrame: 4 months
Secondary outcomes:
measure: Performance characteristics
timeFrame: 4 months
measure: Functionality
timeFrame: 4 months
measure: Longevity
timeFrame: 4 months
measure: skin impact
timeFrame: 4 months
measure: Physical duration
timeFrame: 4 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital, Department of Endokrinology
Study officials:
affiliation: Hospital of Malmo
name: Anders Frid, MD
role: PRINCIPAL_INVESTIGATOR
References: