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

NCT ID: NCT01857375

Last Updated: 2013-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

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.

Conditions

Diabetes

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Group receiving insulin via vial/syringe

This group will receive their insulin via vial/syringe

No interventions assigned to this group

Insulin Pen

Patients receiving insulin via insulin pen

Insulin Pen Device

Intervention Type: DEVICE

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

Interventions

Insulin Pen Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Staten Island University Hospital

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Rothman

Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Rothman, MD

Role: PRINCIPAL_INVESTIGATOR

SIUH

Other Identifiers

09-029

Identifier Type: -

Identifier Source: org_study_id