Type 1 DiabetesPhase 4STAR2NCT00530023

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

A Phase 4 study testing MiniMed Paradigm REAL-Time System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: MiniMed Paradigm REAL-Time System
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: Feb 2006to Sep 2006
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Diabetes Treatment Center, Loma Linda University
Loma Linda, California, 92354
Portland Diabetes & Endocrinology
Portland, Oregon, 97210

Other trials in United States

About this study

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

Read the 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.

Conditions: Type 1 Diabetes
Being tested: MiniMed Paradigm REAL-Time System
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiniMed Paradigm REAL-Time SystemDevice
Also called Medtronic MiniMed Paradigm insulin infusion pump (MMT-722), Transmitter (MMT-7701), Subcutaneous glucose sensor (MMT-7002), Medtronic CareLink Diabetes Management System (MMT-7334)
MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink

Study groups in NCT00530023
Study group	Role	What they receive
1. 722	Active comparator	722 arm: MiniMed Paradigm REAL-Time System Receives: Device: MiniMed Paradigm REAL-Time System
2. Multiple Daily Injections (MDI)	No intervention	MDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 15 weeks

Secondary outcomes (4)

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.
Measured: Baseline and 15 weeks
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.
Measured: Baseline and 15 weeks
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.
Measured: Baseline and 15 weeks
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.
Measured: Baseline and 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Sep 2006

First posted17 Sep 2007 (estimated)
Study startFeb 2006
Primary completionSep 2006
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530023
Sponsor's protocol ID: CEP195/Z25
Acronym: STAR2
Status last verified: May 2011
First submitted: 13 Sep 2007
Last updated: 10 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00530023
Acronym / sponsor ID: STAR2 / CEP195/Z25
Conditions: Type 1 Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 17 Sep 2007 (estimated)
Results: Posted 10 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1. 722	Active comparator	Device: MiniMed Paradigm REAL-Time System722 arm: MiniMed Paradigm REAL-Time System
2. Multiple Daily Injections (MDI)	No intervention	–MDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiniMed Paradigm REAL-Time SystemAlso: Medtronic MiniMed Paradigm insulin infusion pump (MMT-722), Transmitter (MMT-7701), Subcutaneous glucose sensor (MMT-7002), Medtronic CareLink Diabetes Management System (MMT-7334)MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink	Device	1. 722

Primary outcome

Change in A1C From Baseline to Week 15
Time frame: Baseline and 15 weeks
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.

4 secondary outcomes

Incidence of Severe Hypoglycemia Events Baseline to Week 15
Time frame: Baseline and 15 weeks
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
Time frame: Baseline and 15 weeks
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
Time frame: Baseline and 15 weeks
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
Time frame: Baseline and 15 weeks

Results and safety

Results posted to the registry on 10 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
722 Sensor Augmented Insulin Pump	14	14
Multiple Daily Injections (MDI)	15	14

Primary outcome: Change in A1C From Baseline to Week 15

Time frame: Baseline and 15 weeks. Mean (Standard Deviation). Unit: percent glycated hemoglobin

Measure	722 Sensor Augmented Insulin Pump n = 14	Multiple Daily Injections (MDI) n = 14
Value	-1.7 (0.96)	-1.0 (0.97)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
722 Sensor Augmented Insulin Pump	1 of 14 (7.1%)	0 of 14 (0%)	Not reported
Multiple Daily Injections (MDI)	3 of 15 (20%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott W Lee, MD study director

Medtronic MiniMed, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MiniMed Paradigm REAL-Time System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in A1C From Baseline to Week 15 (time frame: Baseline and 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00530023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.