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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Insulin Pen Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group receiving insulin via vial/syringe<br>This group will receive their insulin via vial/syringe | |
| Insulin Pen<br>Patients receiving insulin via insulin pen | Device: Insulin Pen Device<br>* Insulin pen was compared to administration of insulin using standard syringes.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes - insulin administration