NCT01773668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
Last Updated

February 5, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

October 31, 2012

Last Update Submit

February 4, 2013

Conditions

Type 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Performance data

    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 Outcomes (5)

  • Performance characteristics

    4 months

  • Functionality

    4 months

  • Longevity

    4 months

  • skin impact

    4 months

  • Physical duration

    4 months

Study Arms (1)

Integrated sensor and infusion set

EXPERIMENTAL
Device: Integrated sensor and infusion set.

Interventions

Integrated sensor and infusion set.DEVICE
Integrated sensor and infusion set

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital, Department of Endokrinology

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anders Frid, MD

    Hospital of Malmo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

January 23, 2013

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 5, 2013

Record last verified: 2013-01

Locations

SE(1)