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A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe

A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01857375
Enrollment
35
Registered
2013-05-20
Start date
2009-10-31
Completion date
2010-04-30
Last updated
2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes - insulin administration

Brief 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.

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.

Interventions

DEVICEInsulin Pen Device

Insulin pen was compared to administration of insulin using standard syringes.

Sponsors

Staten Island University Hospital
CollaboratorOTHER
Northwell Health
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Previously treated with injectable medicine

Design outcomes

Primary

MeasureTime frameDescription
Insulin Dosing Accuracy (in units)Approximately one yearWhether 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.

Secondary

MeasureTime frame
Reduce the Risk of hypoglycemia (assessed by patient diary)3 months
Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)3 months
Patient satisfaction with method of insulin administration measured by questionnaire.3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026