Clincosm LogoSign in Get a demo

Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

Sponsor
Joslin Diabetes Center (Other)
Overall Status
Completed
CT.gov ID
NCT02914730
Collaborator
(none)
75
Enrollment
1
Location
21.9
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin injections per day. The sample size for this observational study will be up to 125 patients. The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Jul 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Number of Missed Insulin Doses [4 week use of blue tooth pen cap]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 1 diabetes or insulin-requiring Type 2 diabetes

    • 2 insulin injections

    • Age 18-35 or older than 65 years

    • Use of glargine insulin as basal insulin

    • Stable insulin doses for past 3 months

    Exclusion Criteria:

    • Previous tape/adhesive allergies with CGM sensors

    • Visual or cognitive impairment with inability to self-administer insulin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Joslin DIabetes Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Joslin Diabetes Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medha Munshi, Director of Joslin Geriatric Diabetes Programs Beth Israel Deaconess Medical Center Associate Professor of Medicine, Harvard Medical School, Joslin Diabetes Center
    ClinicalTrials.gov Identifier:
    NCT02914730
    Other Study ID Numbers:
    • CHS #2015-47
    First Posted:
    Sep 26, 2016
    Last Update Posted:
    Aug 14, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Medha Munshi, Director of Joslin Geriatric Diabetes Programs Beth Israel Deaconess Medical Center Associate Professor of Medicine, Harvard Medical School, Joslin Diabetes Center
    diabetes
    insulin
    medication adherence
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Aug 14, 2018