Type 1 Diabetes Mellitus
Conditions
Keywords
ASPIRE (Automation to Simulate Pancreatic Insulin Response), X54, Medtronic Diabetes, Diabetes Mellitus, Type 1
Brief 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.
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.
Interventions
DEVICEThe MiniMed Paradigm® X54 System
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.
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. | 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. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to LGS on first and LGS off first | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
Duration (minutes) of induced hypoglycemia (YSI \< 70 mg/dL)
Time frame: approximately 8 hours per induction experiment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON' | The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. | 138.5 minutes | Standard Deviation 76.68 |
| LGS Off: Without Low Glucose Suspend (LGS) Feature | The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. | 170.7 minutes | Standard Deviation 75.91 |
p-value: 0.006ANCOVA
Primary
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
Time frame: approximately 8 hours per induction experiment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON' | The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia. | 10.5 Milligrams per Deciliter | Standard Deviation 5.72 |
| LGS Off: Without Low Glucose Suspend (LGS) Feature | The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia. | 12.5 Milligrams per Deciliter | Standard Deviation 5.69 |
p-value: 0.015ANCOVA