Type 1 Diabetes MellitusNCT01148862
Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
A study testing The MiniMed Paradigm® X54 System in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise. The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- The MiniMed Paradigm® X54 System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to Nov 2011
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject is between the ages of 16 - 60 years old
- A clinical diagnosis of Type 1 Diabetes Mellitus, as determined by the Investigator, for a minimum of 12 months duration
- Subject has been on a Medtronic insulin pump for at least 3 months, which includes but is not limited to those on sensor augmented insulin pump therapy
- Subject has an A1C value between ≥ 7.0% and ≤ 10.0% at time of enrollment; as measured during the screening visit
- Subject must have a documented stress treadmill test within the last three years of enrollment if the subject had diabetes for >20 years
- Subject willing to follow protocol and procedures for study.
Who cannot join
- Systolic blood pressure on screening visit is >140 Millimeters of Mercury
- Diastolic blood pressure on screening visit is >90 Millimeters of Mercury
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the last two years
- Subject unable to tolerate tape adhesive in the area of sensor placement;
- Subject has any active adverse skin condition in the area of sensor placement (i.e. psoriasis, rash, staphylococcus infection) that is not resolved at the time of enrollment
- Subject is pregnant or plans to become pregnant during the course of the study
Show all 26Show fewer
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subject has active Graves disease
- Subject with renal impairment or creatinine above the normal reference range (of the laboratory that the clinical site is utilizing), as demonstrated by the screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for hematocrit, as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for potassium, as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for Thyroid-Stimulating Hormone (TSH), as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for free Thyroxine (T4), as demonstrated by screening laboratory value
- Subject has history of smoking for >5 years
- Electrocardiogram findings observed during the screening visit, which are deemed by the investigator to represent active ischemia or a condition that would compromise subject safety
- The stress treadmill (if subject met inclusion criteria #7) results are deemed by the investigator to represent active ischemia or a condition that would compromise subject safety
- Subject is currently participating in an investigational study (drug or device)
- Subject is currently on beta blocker medication
- Subject has taken oral or injectable steroids within the last 30 days
- Subject is deemed by the Investigator to be unwilling or unable to follow the protocol
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of known illicit drug abuse
- Subject has a history of known abuse with prescription medication
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely per investigator discretion
- Subject has a history of current alcohol abuse
- Any other condition including abnormalities found on the screening tests which in the opinion of the Investigator, may preclude him/her from participating in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Barbara Davis Center of Childhood Diabetes
Aurora, Colorado, 80045
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80045
AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Institute
Renton, Washington, 98057
Stanford University
Stanford, California, 94305
About this study
Official title: An In-clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System With Hypoglycemic Induction From Exercise
The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise.
The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus.
Read the detailed description
50 subjects with previously diagnosed Type 1 Diabetes Mellitus will be studied. The subject population includes the following subsets: 4 pediatric subjects aged 16 -17 years, 4 young adult subjects age 18-21 years, and 42 adult subjects age 22-60 years at time of enrollment. Results for all subjects will be analyzed.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- The MiniMed Paradigm® X54 System
- Keywords
- ASPIRE (Automation to Simulate Pancreatic Insulin Response), X54, Medtronic Diabetes, Diabetes Mellitus, Type 1
- 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.
The MiniMed Paradigm® X54 SystemDevice
Also called MiniMed Paradigm® X54 Pump (X54 Pump)
The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the "Low Glucose Suspend (LGS)" feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated Receives: Device: The MiniMed Paradigm® X54 System |
| Group B | Other | Group B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated Receives: Device: The MiniMed Paradigm® X54 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL)
Measured: approximately 8 hours per induction experiment
The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.
Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level
Measured: approximately 8 hours per induction experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148862
- Sponsor's protocol ID
- CEP235/Z25
- Status last verified
- Mar 2017
- First submitted
- 17 Jun 2010
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Garg S, Brazg RL, Bailey TS, Buckingham BA, Slover RH, Klonoff DC, Shin J, Welsh JB, Kaufman FR. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther. 2012 Mar;14(3):205-9. doi: 10.1089/dia.2011.0292. Epub 2012 Feb 8.
PubMed 22316089
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System With Hypoglycemic Induction From Exercise
- ClinicalTrials.gov ID
- NCT01148862
- Acronym / sponsor ID
- CEP235/Z25
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- ASPIRE (Automation to Simulate Pancreatic Insulin Response), X54, Medtronic Diabetes, Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 30 Mar 2017
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 assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise.
The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus.
Detailed description
50 subjects with previously diagnosed Type 1 Diabetes Mellitus will be studied. The subject population includes the following subsets: 4 pediatric subjects aged 16 -17 years, 4 young adult subjects age 18-21 years, and 42 adult subjects age 22-60 years at time of enrollment. Results for all subjects will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: The MiniMed Paradigm® X54 SystemGroup A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated |
| Group B | Other | Device: The MiniMed Paradigm® X54 SystemGroup B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subject is between the ages of 16 - 60 years old
- A clinical diagnosis of Type 1 Diabetes Mellitus, as determined by the Investigator, for a minimum of 12 months duration
- Subject has been on a Medtronic insulin pump for at least 3 months, which includes but is not limited to those on sensor augmented insulin pump therapy
- Subject has an A1C value between ≥ 7.0% and ≤ 10.0% at time of enrollment; as measured during the screening visit
- Subject must have a documented stress treadmill test within the last three years of enrollment if the subject had diabetes for >20 years
Key exclusion criteria (26 listed)
- Systolic blood pressure on screening visit is >140 Millimeters of Mercury
- Diastolic blood pressure on screening visit is >90 Millimeters of Mercury
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the last two years
- Subject unable to tolerate tape adhesive in the area of sensor placement;
- Subject has any active adverse skin condition in the area of sensor placement (i.e. psoriasis, rash, staphylococcus infection) that is not resolved at the time of enrollment
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 |
|---|---|---|
| The MiniMed Paradigm® X54 SystemAlso: MiniMed Paradigm® X54 Pump (X54 Pump)The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the "Low Glucose Suspend (LGS)" feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends. | Device | Group A, Group B |
Primary outcome
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
Time frame: approximately 8 hours per induction experiment
Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL)
The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.
Time frame: approximately 8 hours per induction experiment
Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22316089Garg S, Brazg RL, Bailey TS, Buckingham BA, Slover RH, Klonoff DC, Shin J, Welsh JB, Kaufman FR. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther. 2012 Mar;14(3):205-9. doi: 10.1089/dia.2011.0292. Epub 2012 Feb 8.
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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.
Bruce Buckingham, MD principal investigator
Stanford University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MiniMed Paradigm® X54 System in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 5 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 26 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 Mar 2017). 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?
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. (time frame: approximately 8 hours per induction experiment). The study lists 2 primary outcomes in all. 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 NCT01148862, which also lists 1 linked publication.
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 30 Mar 2017.