Feasibility Study - Integrated Sensor and Infusion Set. Trial III

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier:
NCT01773668
First received: October 31, 2012
Last updated: February 4, 2013
Last verified: January 2013

October 31, 2012
February 4, 2013
November 2012
January 2013   (final data collection date for primary outcome measure)
Performance data [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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.
Performance data [ Time Frame: 4 months ] [ Designated as safety issue: No ]
The purpose of this study is to collect performance data on the combination infusion set and glucose sensor (Combo-set) during 3 days of use and demonstrate performance adequacy of Combo-set with glucose sensing and insulin delivery functionalities.
Complete list of historical versions of study NCT01773668 on ClinicalTrials.gov Archive Site
  • Performance characteristics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.
  • Functionality [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Gluco-dynamic effect of insulin delivered via the integrated sensor and infusion set demonstrating that insulin was successfully delivered.
  • Longevity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The longevity of the insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear
  • skin impact [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)
  • Physical duration [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Investigational Center and subject's report on physical duration of the Integrated sensor and infusion set assessed in study survey (CFR)
  • Performance characteristics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Comparative analysis of performance characteristics of Combo-set sensors and Enlite sensors will be performed. SMBG data will be used as reference.
  • Functionality [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Gluco-dynamic effect of insulin delivered via Combo-sets demonstrating that insulin was successfully delivered.
  • Longevity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The longevity of the Combo-set insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear
  • skin impact [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Skin condition after Combo-set removal will be evaluated and assessed by the clinical staff in the study survey (CRF)
  • Physical duration [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Investigational Center and subject's report on physical duration of the Combo-set assessed in study survey (CFR)
Not Provided
Not Provided
 
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Type 2 Diabetes
Device: Integrated sensor and infusion set.
Experimental: Integrated sensor and infusion set
Intervention: Device: Integrated sensor and infusion set.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01773668
CEP 271
Not Provided
Medtronic Diabetes R&D Denmark
Medtronic Diabetes R&D Denmark
Not Provided
Principal Investigator: Anders Frid, MD Hospital of Malmo
Medtronic Diabetes R&D Denmark
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP