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
  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. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Device: Integrated sensor and infusion set.

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 17
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated sensor and infusion set Device: Integrated sensor and infusion set.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01773668

Locations
Sweden
Skåne University Hospital, Department of Endokrinology
Malmö, Sweden, 205 02
Sponsors and Collaborators
Medtronic Diabetes R&D Denmark
Investigators
Principal Investigator: Anders Frid, MD Hospital of Malmo
  More Information

No publications provided

Responsible Party: Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier: NCT01773668     History of Changes
Other Study ID Numbers: CEP 271
Study First Received: October 31, 2012
Last Updated: February 4, 2013
Health Authority: Sweden: Central Ethical Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014