Status:
TERMINATED
Pramlintide Combined With Model Predictive Control Algorithm
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
The Paul Manning Foundation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This is a scientific research study that will look at how a "closed-loop" system and the drug Pramlintide may work together to improve blood sugar control in people with type 1 diabetes mellitus. Pram...
Detailed Description
The objective of this study is to test whether standard pramlintide treatment plus a closed-loop insulin therapy is more efficacious in controlling glycemia than either of the individual therapies. Th...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least six months (the diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determination are not needed).
- Age 21 to 65 years
- For females, not currently known to be pregnant
- An understanding of the protocol and a willingness to follow it
- HbA1c between 7 and 9%
- Normal renal function (determined utilizing the comprehensive metabolic panel at screening with the Modification of Diet in Renal Disease (MDRD) formula and defined by estimated Glomerular Filtration Rate (eGFR) of ≥60 ml/min/1.73 m2.
- Hematocrit \>36 (females); \>38 (males)
Exclusion
- Known hypersensitivity to SYMLIN or any of its components, including metacresol
- Poor compliance with current insulin regimen
- Poor compliance with prescribed self-blood glucose monitoring
- HbA1c \<7 or \>9%
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to enrollment
- Active infection
- Current use of dietary supplements (subjects may be enrolled if they stop taking dietary supplements two weeks prior to admission and for the duration of their participation)
- Active gastroparesis
- Use of drugs that stimulate gastrointestinal motility (e.g. metoclopramide)
- Diabetic ketoacidosis in the past 3 months
- Current treatment for a seizure disorder
- Cystic fibrosis
- Asthma requiring hospitalization or treatment with oral steroids within the past year
- Presence of a uncontrolled adrenal disorder
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Abnormal liver function (Transaminase \>2 times the upper limit of normal)
- Heart failure
- Coronary artery disease
- Arrhythmia
- Seizure disorder
- Any carcinogenic disease
- Creatinine concentration above the upper limit of normal for age and sex
- Active coronary artery disease
- Uncontrolled thyroid disease
- Use or abuse of alcohol
- Active kidney dialysis
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Note: adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Addison's disease
- Current use of a beta blocker medication
- Hematocrit \< 36 (female), \<38 (male)
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Allergy to the sensor or to one of its components
- Continued use of acetaminophen.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01434862
Start Date
February 1 2011
End Date
February 1 2012
Last Update
May 1 2014
Active Locations (1)
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1
University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903