Skip to main content
OpenTrials
Completed

NCT Number: NCT01857375

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Pen Device

Device

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

Primary outcomes

  1. Insulin Dosing Accuracy (in units)

    Time frame: 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 outcomes

  1. Reduce the Risk of hypoglycemia (assessed by patient diary)

    Time frame: 3 months

  2. Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)

    Time frame: 3 months

  3. Patient satisfaction with method of insulin administration measured by questionnaire.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Staten Island University Hospital

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 20, 2013
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.