Pramlintide Combined With Model Predictive Control Algorithm

Stopped early · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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. Pramlintide is approved by the Food and Drug Administration (FDA) and is given as an injection (subcutaneous) that works with insulin to lower blood sugar.

Key facts

Study ID

NCT01434862

Run by

University of Virginia

People needed

2

Starts

2011-02-01

Expected to finish

2012-02-01

Last updated by the study team

2014-05-01

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Virginia, Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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