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NCT02914730 Clinical Trial

Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02914730
Other study ID # CHS #2015-47
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date July 2018

Study information
Verified date August 2018
Source Joslin Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Joslin DIabetes Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Missed Insulin Doses 4 week use of blue tooth pen cap
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