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Connected Pens for Diabetes Study

NCT03830216 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-01-27

No results posted yet for this study

Summary

The objective of the study is to evaluate the impact of a wireless smart insulin pen and smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated diabetes mellitus patients after 3 months of use.

Conditions

Interventions

DEVICE

Connected insulin pen and smartphone app

The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is paired with a smartphone app with dose calculator.

DEVICE

Inactive connected insulin pen without smartphone app

The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is inactive and not paired with a smartphone app or dose calculator.

Sponsors & Collaborators

  • Companion Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • David Ahn, MD · Hoag Memorial Hospital Presbyterian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2019-11-12
Completion
2019-11-12
FDA Device
Yes

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 NCT03830216 on ClinicalTrials.gov