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Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes

NCT04090242 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-07-08

Study results available
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Summary

This is a multi-center, open-label, parallel-group, randomized controlled study in subjects with type 2 diabetes using multiple daily injection (MDI) insulin therapy. Subjects will be randomized to either receive the DC App and BD Nano 2nd Gen pen needles (intervention) or continue their standard of care using their current pen needle and diabetes management (control). The study will consist of four visits and two scheduled phone calls across a total of 10 weeks.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle

Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Edward Mahoney, PhD · Becton Dickinson

  • David Klonoff, M.D, FACP · Diabetes Research Institute, Mills-Peninsula Medical Center, California

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2020-06-12
Completion
2020-06-12
FDA Device
Yes

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 NCT04090242 on ClinicalTrials.gov