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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
- ClinicalTrials.gov ID
- NCT02914730
- Acronym / sponsor ID
- CHS #2015-47
- Conditions
- Diabetes, Medication Adherence, Technology, Insulin
- Keywords
- diabetes, insulin, medication adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Previous tape/adhesive allergies with CGM sensors
- Visual or cognitive impairment with inability to self-administer insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Missed Insulin Doses
Time frame: 4 week use of blue tooth pen cap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 30862650Munshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Medication Adherence, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Missed Insulin Doses (time frame: 4 week use of blue tooth pen cap). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.