Pramlintide Combined With Model Predictive Control Algorithm

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborators: The Paul Manning Foundation; The Paul Manning Foundation (private)
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.