Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Glargine insulin

• Registration Number: NCT01203774
• Lead Sponsor: University of Colorado, Denver

Brief Summary

In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2021-07
• Results First Submitted: 2021-07-15
• Results First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Results First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine

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Exclusion Criteria

• Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pen-administered vs syringe-admnistered Glargine	Glargine insulin	SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin
Syringe-administered vs pen-administered Glargine	Glargine insulin	Syringe-administered Glargine insulin and then pen-administered Glargine insulin

Primary Outcome Measures

Name	Time	Method
HbA1c at Three Months of Each Period of Treatment	Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)	Data was collected by group

Secondary Outcome Measures

Name	Time	Method
Compliance and Patient Satisfaction	6 months of treatment after discharge from the hospital

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States