Type 1 DiabetesSTAR1NCT00211510
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
A study testing Paradigm 722 sensor augmented pump and Paradigm 715 insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Paradigm 722 sensor augmented pump and Paradigm 715 insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2005to Feb 2007
- Phase
- Interventional
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 - 80 years
- Type 1 Diabetes Mellitus diagnosed at least 1 year ago
- Using insulin infusion pump for past 6 months minimum
- Performing minimum 4 blood glucose tests per day
- Agree to treat to A1c targets
- Read and understand English
Who cannot join
- Pregnant or planning pregnancy
- History of unresolved tape allergy or skin conditions
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Endocrine Group
Albany, New York, 12206
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Joslin Diabetes Center
Boston, Massachusetts, 02215
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Diabetes and Glandular Diabetes Research Associates
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
About this study
Official title: Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
Read the detailed description
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
- Conditions
- Type 1 Diabetes
- Being tested
- Paradigm 722 sensor augmented pump, Paradigm 715 insulin pump
- Keywords
- Diabetes, Continuous Glucose Monitoring, Glycemic Control
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paradigm 722 sensor augmented pumpDevice
Also called 722 pump
Subjects use the Paradigm 722 sensor augmented pump
Paradigm 715 insulin pumpDevice
Also called 715 pump
Subjects use the Paradigm 715 insulin pump
| Study group | Role | What they receive |
|---|---|---|
| Paradigm 722 sensor augmented pump | Experimental | subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring Receives: Device: Paradigm 722 sensor augmented pump |
| Paradigm 715 insulin pump | Active comparator | subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin Receives: Device: Paradigm 715 insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c From Baseline to 26 Weeks
Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
Measured: Baseline and 26 weeks
Secondary outcomes (5)
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.
Measured: Baseline and 26 weeks
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26
Measured: Baseline and 26 weeks
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26
Measured: Baseline and 26 weeks
Glucose Sensor Accuracy as Measured in the 722 Group
Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).
Measured: Baseline and 26 weeks
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.
Measured: Baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2006
- Study completionFeb 2007
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott W Lee, MD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211510
- Sponsor's protocol ID
- CEP 178/Z25/A2
- Acronym
- STAR1
- Status last verified
- May 2017
- First submitted
- 12 Sep 2005
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00211510
- Acronym / sponsor ID
- STAR1 / CEP 178/Z25/A2
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Continuous Glucose Monitoring, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 29 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
Detailed description
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paradigm 722 sensor augmented pump | Experimental | Device: Paradigm 722 sensor augmented pumpsubjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring |
| Paradigm 715 insulin pump | Active comparator | Device: Paradigm 715 insulin pumpsubjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 12 - 80 years
- Type 1 Diabetes Mellitus diagnosed at least 1 year ago
- Using insulin infusion pump for past 6 months minimum
- Performing minimum 4 blood glucose tests per day
- Agree to treat to A1c targets
Key exclusion criteria (2 listed)
- Pregnant or planning pregnancy
- History of unresolved tape allergy or skin conditions
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 |
|---|---|---|
| Paradigm 722 sensor augmented pumpAlso: 722 pumpSubjects use the Paradigm 722 sensor augmented pump | Device | Paradigm 722 sensor augmented pump |
| Paradigm 715 insulin pumpAlso: 715 pumpSubjects use the Paradigm 715 insulin pump | Device | Paradigm 715 insulin pump |
Primary outcome
Change in A1c From Baseline to 26 Weeks
Time frame: Baseline and 26 weeks
Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
5 secondary outcomes
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
Time frame: Baseline and 26 weeks
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
Time frame: Baseline and 26 weeks
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
Time frame: Baseline and 26 weeks
Glucose Sensor Accuracy as Measured in the 722 Group
Time frame: Baseline and 26 weeks
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
Time frame: Baseline and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paradigm 722 sensor augmented pump and Paradigm 715 insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 7 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 6 inclusion and 2 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 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 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 26 Weeks (time frame: Baseline and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2017.