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Feasibility Study of an Integrated Sensor and Infusion Set

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier:
NCT01770561
First received: August 15, 2012
Last updated: February 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Diabetes Type 1
Device: Integrated sensor and infusion set.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes R&D Denmark:

Primary Outcome Measures:
  • Comparative analysis of performance characteristics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Gluco-dynamic effect [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Performance longevity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Longevity of device performance will be assessed by comparing the listed parameters obtained during visits 3 and 4.


Secondary Outcome Measures:
  • Skin condition [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Skin condition after removal of the device will be evaluated and assessed by the clinical staff in a study survey

  • Physical duration [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Investigational Center and subject's report on physical duration of the device assessed in study survey Subjects' experiences are gathered in study surveys.


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated sensor and infusion set.
All subjects must have been previously diagnosed Type 1 Diabetics and being used to sensor augumented pumps
Device: Integrated sensor and infusion set.
Change patients from current devices to the Integrated sensor and infusion set.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 21-70 years of age at time of screening
  2. Subject has a clinical diagnose of type 1 diabetes, as determined by investigator
  3. Subject has one or more established insulin-to-carbohydrate ratios
  4. Subject has one or more established insulin correction ratios
  5. Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
  6. Subject has been using insulin for more than one year.
  7. Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
  8. Subject is willing to perform frequent SMBGs during Visits 3 and 4.
  9. Subject is in good general health without other acute or chronic illnesses

Exclusion Criteria:

  1. Subject is pregnant or lactating (if female), as self-declared by patient
  2. Subject plans to become pregnant during the course of the study
  3. Subject is unable to tolerate tape adhesive in the area of sensor placement
  4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
  5. 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.
  6. 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.
  7. The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770561

Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Medtronic Diabetes R&D Denmark
Investigators
Principal Investigator: Kirsten Noergaard, MDD Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier: NCT01770561     History of Changes
Other Study ID Numbers: CER269
Study First Received: August 15, 2012
Last Updated: February 4, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014