Pramlintide Combined With Model Predictive Control Algorithm

NCT01434862 | Terminated

• 1 other identifier: 15401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percent of Blood glucose tests within target range of 70 to 180 mg/dl

  Percent of Blood glucose tests within target range of 70 to 180 mg/dl The primary outcome variable of glucose control within an American Diabetes Association (ADA) standard target range between 70 mg/dl to 180 mg/dl on a Yellow Springs Instrument (YSI) glucose analyzer. This is based upon the sample size estimate difference expected for % time within target range between artificial pancreas vs. patient control vs. Pramlintide plus artificial pancreas.

  24 hours

Secondary Outcomes (1)

• Percent of Continuous Glucose Monitoring (CGM) System estimated blood glucose within target range of 70 to 180 mg/dl

  72 hours

Study Arms (3)

Closed loop with pramlintide

EXPERIMENTAL

Pramlintide will be provided to study subjects who will subsequently be admitted for inpatient testing with the closed loop system. The term closed loop refers to insulin adjustment automatically regulated by computer input to the insulin pump based on monitoring (often a combination of patient blood glucose (BG) testing and/or continuous glucose monitoring (CGM)).

Drug: Closed loop with pramlintide

Closed loop without pramlintide

EXPERIMENTAL

This visit is necessary to assess how well the closed loop system works without the pramlintide (how well it protects from hypoglycemia and hyperglycemia). It will be the exact protocol as for the closed loop with pramlintide but without the medication.

Device: Closed loop without pramlintide

Open loop with pramlintide

EXPERIMENTAL

The term open loop refers to insulin infusions regulated in their delivery based on patient self-monitoring and adjustment. The study subject will be in charge of their insulin treatment while also receiving pramlintide.

Drug: Open loop with pramlintide

Interventions

Closed loop with pramlintide DRUG

Dose of pramlintide will be titrated based on subject's current prescribed dose. The target dose is 60 mcq three times daily.

Closed loop with pramlintide

Closed loop without pramlintide DEVICE

This visit will assess how well the closed loop system works without the pramlintide.

Closed loop without pramlintide

Open loop with pramlintide DRUG

Dose of pramlintide will be titrated based on subject's current prescribed dose. The target dose is 60 mcq three times daily.

Open loop with pramlintide

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• University of Virginia: lead
• The Paul Manning Foundation: collaborator

Study Sites (1)

University of Virginia, Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anthony McCall, M.D., Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Diabetes

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 15, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

US (1)