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Feasibility Study of an Integrated Sensor and Infusion Set

Primary Purpose

Diabetes Type 1

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Integrated sensor and infusion set.
Sponsored by
Medtronic Diabetes R&D Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Type 1

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated sensor and infusion set.

Arm Description

All subjects must have been previously diagnosed Type 1 Diabetics and being used to sensor augumented pumps

Outcomes

Primary Outcome Measures

Comparative analysis of performance characteristics
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
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
Longevity of device performance will be assessed by comparing the listed parameters obtained during visits 3 and 4.

Secondary Outcome Measures

Skin condition
Skin condition after removal of the device will be evaluated and assessed by the clinical staff in a study survey
Physical duration
Investigational Center and subject's report on physical duration of the device assessed in study survey Subjects' experiences are gathered in study surveys.

Full Information

First Posted
August 15, 2012
Last Updated
February 4, 2013
Sponsor
Medtronic Diabetes R&D Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01770561
Brief Title
Feasibility Study of an Integrated Sensor and Infusion Set
Official Title
Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes R&D Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated sensor and infusion set.
Arm Type
Experimental
Arm Description
All subjects must have been previously diagnosed Type 1 Diabetics and being used to sensor augumented pumps
Intervention Type
Device
Intervention Name(s)
Integrated sensor and infusion set.
Intervention Description
Change patients from current devices to the Integrated sensor and infusion set.
Primary Outcome Measure Information:
Title
Comparative analysis of performance characteristics
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 set sensors compare to control Enlite sensors.
Time Frame
4 months
Title
Gluco-dynamic effect
Description
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.
Time Frame
4 months
Title
Performance longevity
Description
Longevity of device performance will be assessed by comparing the listed parameters obtained during visits 3 and 4.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Skin condition
Description
Skin condition after removal of the device will be evaluated and assessed by the clinical staff in a study survey
Time Frame
4 months
Title
Physical duration
Description
Investigational Center and subject's report on physical duration of the device assessed in study survey Subjects' experiences are gathered in study surveys.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 21-70 years of age at time of screening Subject has a clinical diagnose of type 1 diabetes, as determined by investigator Subject has one or more established insulin-to-carbohydrate ratios Subject has one or more established insulin correction ratios 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: Subject is pregnant 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Noergaard, MDD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Feasibility Study of an Integrated Sensor and Infusion Set

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