- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261052
Real-time Adaptation to Changes in Insulin Sensitivity
Sensor-Controlled Insulin and Glucagon Delivery in Subjects With Type 1 Diabetes: Real-time Adaptation to Changes in Insulin Sensitivity
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97210
- Legacy Good Samaritan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Type 1 Diabetes Mellitus for at least 1 year
- Male or Female subjects 21 to 65 years of age
- Willingness to follow all study procedures, including attending all clinic visits
- Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
- Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
- Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
- Adrenal insufficiency
- Hematocrit of less than or equal to 34%.
- A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.
- Congestive heart failure, NYHA class III or IV.
- Cardiac rhythm disturbance characterized by: 2nd or 3rd degree heart block, bradycardia of less than 50 bpm (exception of bradycardia in an aerobic athlete), tachycardia of greater than 100 bpm, or any arrhythmia judged by the investigator to be exclusionary.
- Any active infection.
- Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
- Physical impairment impeding the ability to use a glucose meter or glucose monitoring device.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
- Active malignancy, except basal cell or squamous cell skin cancers.
- Major surgical operation within 30 days prior to screening.
- Seizure disorder.
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Current administration of oral or parenteral corticosteroids.
- Use of an investigational drug within 30 days prior to screening.
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- History of major non-compliance.
- Allergy to aspart insulin.
- Allergy to glucagon.
- Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment of acetaminophen.
- Intolerance of mild hypoglycemia (glucose 60-70 mg/dl).
- Patients using all dietary supplements (except for vitamin supplements, calcium or vitamin D in standard doses).
- Patients with a history of glaucoma or who have not had an ophthalmologic exam in the previous 2 years (because of the risk of increased intraocular pressure)
- Patients with a history of psychiatric disease or steroid-induced psychosis.
- Patients currently on estrogen supplementation (low dose estrogen contraceptives are not exclusionary).
- Chronic use of dietary supplements that contain adrenal cell extracts, adrenal cortical extracts, or other hormones.
- The use of dietary supplements (except for vitamin supplements, calcium or vitamin D in standard doses) will be exclusionary (unless the subjects agrees to abstain from taking such supplements for three weeks before beginning the study.
- Administration of an immunization (such as a flu or travel immunization) or plans to receive such an immunization within one week of beginning of the study.
- Any reason the principal investigator deems exclusionary.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FMPD/APD intervention
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours.
For the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose.
After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours.
|
The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin. |
Active Comparator: APD only intervention
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours.
For the entire study, the adaptive component or APD will be used to control the subject's blood glucose.
|
The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity
Time Frame: all 33 hour studies
|
The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.
|
all 33 hour studies
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.
Time Frame: all 33 hour studies
|
Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).
|
all 33 hour studies
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010.005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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