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Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

NCT00922649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-09-21

No results posted yet for this study

Summary

16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3) basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.

Conditions

Interventions

DEVICE

Insulin Pump therapy

Initiation of Insulin pump therapy in patients on \>2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.

Sponsors & Collaborators

  • Animas Corporation

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD · AMCR Institute, Inc.

  • Bruce Bode, MD · Atlanta Diabetes Associates, Inc.

  • Mark Kipnes, MD · dgd Research, Inc.

  • John Liljenquist, MD · Rocky Mountain Diabetes and Osteoporosis Center, PA

  • Lyle Myers, M.D · Kentucky Diabetes Endocrinology Center

  • Sunder Mudaliar, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-01
Primary Completion
2008-12-01
Completion
2009-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00922649 on ClinicalTrials.gov