Feasibility Study - Integrated Sensor and Infusion Set. Trial III

Type 2 Diabetes Clinical Trial

Official title:

FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773668
• Other study ID #: CEP 271
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: February 4, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Medtronic Diabetes R&D Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• Integrated sensor and infusion set.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital, Department of Endokrinology	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes R&D Denmark

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Performance characteristics	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.	4 months	No
Secondary	Functionality	Gluco-dynamic effect of insulin delivered via the integrated sensor and infusion set demonstrating that insulin was successfully delivered.	4 months	No
Secondary	Longevity	The longevity of the insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear	4 months	No
Secondary	skin impact	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)	4 months	No
Secondary	Physical duration	Investigational Center and subject's report on physical duration of the Integrated sensor and infusion set assessed in study survey (CFR)	4 months	No