- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773668
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
February 4, 2013 updated by: Medtronic Diabetes R&D Denmark
FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malmö, Sweden, 205 02
- Skåne University Hospital, Department of Endokrinology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Integrated sensor and infusion set
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance data
Time Frame: 4 months
|
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.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance characteristics
Time Frame: 4 months
|
Comparative analysis of performance characteristics of the sensors of the Integrated sensor and infusion set with the Enlite sensors will be performed.
SMBG data will be used as reference.
|
4 months
|
Functionality
Time Frame: 4 months
|
Gluco-dynamic effect of insulin delivered via the integrated sensor and infusion set demonstrating that insulin was successfully delivered.
|
4 months
|
Longevity
Time Frame: 4 months
|
The longevity of the insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear
|
4 months
|
skin impact
Time Frame: 4 months
|
Skin condition after removal of the integrated sensor and infusion set will be evaluated and assessed by the clinical staff in the study survey (CRF)
|
4 months
|
Physical duration
Time Frame: 4 months
|
Investigational Center and subject's report on physical duration of the Integrated sensor and infusion set assessed in study survey (CFR)
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anders Frid, MD, Hospital of Malmo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
October 31, 2012
First Submitted That Met QC Criteria
January 18, 2013
First Posted (ESTIMATE)
January 23, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 4, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP 271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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