DiabetesNCT02914730
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
An observational study of Diabetes and Medication Adherence, run by Joslin Diabetes Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Medication Adherence, Technology
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jul 2018
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previous tape/adhesive allergies with CGM sensors
- Visual or cognitive impairment with inability to self-administer insulin
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes, Medication Adherence, Technology, Insulin
- Keywords
- diabetes, insulin, medication adherence
- Medical subject headings
- Diabetes Mellitus, Medication Adherence, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Missed Insulin Doses
Measured: 4 week use of blue tooth pen cap
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medha Munshi, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914730
- Sponsor's protocol ID
- CHS #2015-47
- Status last verified
- Aug 2018
- First submitted
- 22 Sep 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
Publications
Munshi MN, Slyne C, Greenberg JM, Greaves T, Lee A, Carl S, Atakov-Castillo A, Toschi E. Nonadherence to Insulin Therapy Detected by Bluetooth-Enabled Pen Cap Is Associated With Poor Glycemic Control. Diabetes Care. 2019 Jun;42(6):1129-1131. doi: 10.2337/dc18-1631. Epub 2019 Mar 12.
PubMed 30862650