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

Completed

• Conditions: Diabetes
• Interventions: Device: Insulin Pen Device

• Registration Number: NCT01857375
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin Pen	Insulin Pen Device	Patients receiving insulin via insulin pen

Primary Outcome Measures

Name	Time	Method
Insulin Dosing Accuracy (in units)	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.

Secondary Outcome Measures

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