DiabetesNCT01857375
A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe
An observational study of Diabetes, run by Northwell Health.
Trial summary
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulin Pen Device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults newly begun on insulin therapy during their hospital stay.
Who may be able to join
- Adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. They must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses.
Who cannot join
- Previously treated with injectable medicine
About this study
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.
Read the detailed description
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Patients will have no prior experience using insulin or other self-administered injectable medicine. The study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.
- Conditions
- Diabetes
- Being tested
- Insulin Pen Device
- Keywords
- Diabetes - insulin administration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Pen DeviceDevice
Insulin pen was compared to administration of insulin using standard syringes.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving insulin via vial/syringe | This group will receive their insulin via vial/syringe | |
| Insulin Pen | Patients receiving insulin via insulin pen Receives: Device: Insulin Pen Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Dosing Accuracy (in units)
Whether the method of administering insulin would: 1) reduce dosing errors as measured by direct observation of patient performance, 2) reduce the risk of hypoglycemia, 3) increase adherence to insulin, 4) improve patient satisfaction.Dosing accuracy was measured by direct observation of subject's performance at follow-up visits.
Measured: Approximately one year
Secondary outcomes (3)
Reduce the Risk of hypoglycemia (assessed by patient diary)
Measured: 3 months
Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)
Measured: 3 months
Patient satisfaction with method of insulin administration measured by questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Jeffrey Rothman, Northwell Health
- Investigators
- Jeffrey Rothman, MD, Principal investigator, SIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857375
- Sponsor's protocol ID
- 09-029
- Status last verified
- May 2013
- First submitted
- 13 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe
- ClinicalTrials.gov ID
- NCT01857375
- Acronym / sponsor ID
- 09-029
- Conditions
- Diabetes
- Keywords
- Diabetes - insulin administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 May 2013 (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.
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.
Detailed description
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Patients will have no prior experience using insulin or other self-administered injectable medicine. The study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving insulin via vial/syringe | – | –This group will receive their insulin via vial/syringe |
| Insulin Pen | – | Device: Insulin Pen DevicePatients receiving insulin via insulin pen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults newly begun on insulin therapy during their hospital stay.
Key inclusion criteria (1 listed)
- Adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. They must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses.
Key exclusion criteria (1 listed)
- Previously treated with injectable medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Pen DeviceInsulin pen was compared to administration of insulin using standard syringes. | Device | Insulin Pen |
Primary outcome
Insulin Dosing Accuracy (in units)
Time frame: Approximately one year
Whether the method of administering insulin would: 1) reduce dosing errors as measured by direct observation of patient performance, 2) reduce the risk of hypoglycemia, 3) increase adherence to insulin, 4) improve patient satisfaction.Dosing accuracy was measured by direct observation of subject's performance at follow-up visits.
3 secondary outcomes
Reduce the Risk of hypoglycemia (assessed by patient diary)
Time frame: 3 months
Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)
Time frame: 3 months
Patient satisfaction with method of insulin administration measured by questionnaire.
Time frame: 3 months
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 21 May 2013.
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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.
Jeffrey Rothman, MD principal investigator
SIUH
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Northwell Health.
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 1 inclusion and 1 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Insulin Dosing Accuracy (in units) (time frame: Approximately one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2013.