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Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness (STAR2)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MiniMed Paradigm REAL-Time System
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is between 18 - 70 years of age (inclusive)
  • Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator.
  • Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry.
  • A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1.
  • Subject currently requires insulin administration by injection > (greater or equal to) three (3) times daily.
  • Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator
  • Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study
  • Subject is fluent in speaking, understanding, and reading English.
  • Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period.
  • Subject is able to use the study devices (722 Arm only) as labeled
  • Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only).
  • Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study

Exclusion Criteria:

  • Subject is pregnant or planning to become pregnant during the course of the study.
  • Subject has a history of tape allergies that have not been resolved.
  • Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection).
  • Subject has any additional condition(s) (medical, social, or psychosocial) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing or complying with the study requirements.
  • Subject is currently or within past 4 weeks participated in an investigational study (drug or device).

Subject has a history of tape allergies that have not been resolved.

Sites / Locations

  • Diabetes Treatment Center, Loma Linda University
  • Portland Diabetes & Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1. 722

2. Multiple Daily Injections (MDI)

Arm Description

722 arm: MiniMed Paradigm REAL-Time System

MDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.

Outcomes

Primary Outcome Measures

Change in A1C From Baseline to Week 15
Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.

Secondary Outcome Measures

Incidence of Severe Hypoglycemia Events Baseline to Week 15
The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.

Full Information

First Posted
September 13, 2007
Last Updated
May 9, 2011
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT00530023
Brief Title
Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
Acronym
STAR2
Official Title
Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial
Detailed Description
Many subjects with Type 1 diabetes continue to manage their disease utilizing multiple daily injections, but despite frequent blood glucose checks, are unable to control their glycemic variability or lower their A1C levels. The MiniMed Paradigm REAL-Time System transmits sensor glucose values to the insulin pump every 5 minutes, allowing users to view their current glucose values as well as glycemic excursions and trends over a 24-hour period. The System will also alert users of high and low glucose levels, allowing subjects and their clinicians to make carefully monitored modifications to therapy. Additionally, data can be uploaded from the monitor into a personal computer, allowing the subject and clinician to see a complete picture of trends over time. Subjects learning this technology would require a new approach to training if they were to master operation of an insulin pump, make effective use of the sensor technology and understand the complete picture provided by the software component. Subjects will be trained to first use the insulin pump, add the sensor and then utilize the software and the effectiveness of the training methods and timing will be measured using questionnaires designed to evaluate understanding of the device, Self Efficacy and User Acceptance. The group wearing the System will also be compared to subjects that continue on their current MDI therapy over a 15-week time period.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. 722
Arm Type
Active Comparator
Arm Description
722 arm: MiniMed Paradigm REAL-Time System
Arm Title
2. Multiple Daily Injections (MDI)
Arm Type
No Intervention
Arm Description
MDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.
Intervention Type
Device
Intervention Name(s)
MiniMed Paradigm REAL-Time System
Other Intervention Name(s)
Medtronic MiniMed Paradigm insulin infusion pump (MMT-722), Transmitter (MMT-7701), Subcutaneous glucose sensor (MMT-7002), Medtronic CareLink Diabetes Management System (MMT-7334), Paradigm Link Glucose Meter (HMS-322200A)
Intervention Description
MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
Primary Outcome Measure Information:
Title
Change in A1C From Baseline to Week 15
Description
Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.
Time Frame
Baseline and 15 weeks
Secondary Outcome Measure Information:
Title
Incidence of Severe Hypoglycemia Events Baseline to Week 15
Description
The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.
Time Frame
Baseline and 15 weeks
Title
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
Description
Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Time Frame
Baseline and 15 weeks
Title
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
Description
Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Time Frame
Baseline and 15 weeks
Title
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
Description
Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.
Time Frame
Baseline and 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is between 18 - 70 years of age (inclusive) Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator. Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry. A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1. Subject currently requires insulin administration by injection > (greater or equal to) three (3) times daily. Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study Subject is fluent in speaking, understanding, and reading English. Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period. Subject is able to use the study devices (722 Arm only) as labeled Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only). Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study Exclusion Criteria: Subject is pregnant or planning to become pregnant during the course of the study. Subject has a history of tape allergies that have not been resolved. Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection). Subject has any additional condition(s) (medical, social, or psychosocial) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing or complying with the study requirements. Subject is currently or within past 4 weeks participated in an investigational study (drug or device). Subject has a history of tape allergies that have not been resolved.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Lee, MD
Organizational Affiliation
Medtronic Diabetes
Official's Role
Study Director
Facility Information:
Facility Name
Diabetes Treatment Center, Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Portland Diabetes & Endocrinology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

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Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness

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