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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Insulin Pen Device

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 Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults newly begun on insulin therapy during their hospital stay.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group receiving insulin via vial/syringe; This group will receive their insulin via vial/syringe
Insulin Pen; Patients receiving insulin via insulin pen	Device: Insulin Pen Device; Insulin pen was compared to administration of insulin using standard syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Staten Island University Hospital
• Investigators: Principal Investigator: Jeffrey Rothman, MD, SIUH

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (ESTIMATE): May 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes - insulin administration
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 09-029