- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914730
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
August 10, 2018 updated by: Medha Munshi, Joslin Diabetes Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Missed Insulin Doses
Time Frame: 4 week use of blue tooth pen cap
|
4 week use of blue tooth pen cap
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimate)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
August 14, 2018
Last Update Submitted That Met QC Criteria
August 10, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHS #2015-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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