- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770561
Feasibility Study of an Integrated Sensor and Infusion Set
Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD (absolute relative difference), median ARD, Clarke Grid Analysis. Meter BG values will be used as reference. Descriptive statistics will be used to assess non-inferiority of the Integrated sensor and infusion sets sensors compare to control Enlite sensors.
Insulin delivery functionality will be evaluated based on BG profiles obtained during peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min intervals according to a SMBG schedule. Post-prandial pharmacodynamic profiles will be analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and infusion set. Specifically, rise in glucose levels followed by their fall will be used as an indication that insulin was delivered and absorbed. Post-prandial BG areas under the curve (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days and compared. Intra - and inter-subject mean values and standard deviations will be calculated. Paired and unpaired T-tests will be used to evaluate statistical significance.
Longevity of device performance will be assessed by comparing the listed parameters obtained during two inpatient days.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hvidovre, Denmark, 2650
- Hvidovre Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is 21-70 years of age at time of screening
- Subject has a clinical diagnose of type 1 diabetes, as determined by investigator
- Subject has one or more established insulin-to-carbohydrate ratios
- Subject has one or more established insulin correction ratios
- 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:
- Subject is pregnant 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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Integrated sensor and infusion set.
All subjects must have been previously diagnosed Type 1 Diabetics and being used to sensor augumented pumps
|
Change patients from current devices to the Integrated sensor and infusion set.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparative analysis of performance characteristics
Time Frame: 4 months
|
Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD (absolute relative difference), median ARD, Clarke Grid Analysis.
Meter BG values will be used as reference.
Descriptive statistics will be used to assess non-inferiority of the Integrated sensor and infusion set sensors compare to control Enlite sensors.
|
4 months
|
Gluco-dynamic effect
Time Frame: 4 months
|
Insulin delivery functionality will be evaluated based on BG profiles obtained during peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min intervals according to the SMBG schedule.
Post-prandial pharmacodynamic profiles will be analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and infusion set.
Specifically, rise in glucose levels followed by their fall will be used as an indication that insulin was delivered and absorbed.
Post-prandial BG areas under the curve (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days (visits 3 and 4) and compared.
Intra - and inter-subject mean values and standard deviations will be calculated.
Paired and unpaired T-tests will be used to evaluate statistical significance.
|
4 months
|
Performance longevity
Time Frame: 4 months
|
Longevity of device performance will be assessed by comparing the listed parameters obtained during visits 3 and 4.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin condition
Time Frame: 4 months
|
Skin condition after removal of the device will be evaluated and assessed by the clinical staff in a study survey
|
4 months
|
Physical duration
Time Frame: 4 months
|
Investigational Center and subject's report on physical duration of the device assessed in study survey Subjects' experiences are gathered in study surveys.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirsten Noergaard, MDD, Hvidovre University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER269
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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