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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857375
• Other study ID #: 09-029
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 20, 2013
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Insulin Pen Device
Insulin pen was compared to administration of insulin using standard syringes.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately one year	Yes
Secondary	Reduce the Risk of hypoglycemia (assessed by patient diary)		3 months	Yes
Secondary	Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)		3 months	Yes
Secondary	Patient satisfaction with method of insulin administration measured by questionnaire.		3 months	No