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

NCT01857375 | Completed DMC

• 1 other identifier: 09-029
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Keywords

Diabetes - insulin administration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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

Interventions

Insulin Pen Device DEVICE

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

Insulin Pen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults newly begun on insulin therapy during their hospital stay.

You may qualify if:

• 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.

You may not qualify if:

• Previously treated with injectable medicine

Sponsors & Collaborators

• Northwell Health: lead
• Staten Island University Hospital: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jeffrey Rothman, MD

  SIUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinology

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 20, 2013
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 21, 2013

Record last verified: 2013-05