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Pramlintide Combined With Model Predictive Control Algorithm

NCT01434862 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-05-01

No results posted yet for this study

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

Interventions

DRUG

Closed loop with pramlintide

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

DEVICE

Closed loop without pramlintide

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

DRUG

Open loop with pramlintide

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

Sponsors & Collaborators

  • The Paul Manning Foundation

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Anthony McCall, M.D., Ph.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434862 on ClinicalTrials.gov