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Standard Insulin Administration Education for Type 2 Diabetes (I-START Trial)

N/A
Waitlist Available
Led By Linda Siminerio, RN, PhD, CDE
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

I-START Trial Summary

This study is evaluating whether an educational phone application may help improve insulin administration for individuals with type 2 diabetes.

I-START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in psychological insulin resistance at 2 weeks
Change from baseline in psychological insulin resistance at 3 months
Change from baseline in psychological insulin resistance at 6 months
Secondary outcome measures
Change from baseline in diabetes distress at 3 months
Change from baseline in diabetes distress at 6 months
Change from baseline in diabetes empowerment at 3 months
+7 more
Other outcome measures
Patient Usability
Provider usability

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

I-START Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Participants assigned to the intervention group will receive insulin administration education according to standard procedures plus have access to the I-START app. Over the course of the study period, participants will be able to use I-START as much or as little as they prefer.
Group II: Usual CareActive Control1 Intervention
Participants in the usual care group will receive insulin administration education according to standard procedures. They will not have access to the I-START app.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Insulin Administration Education
2019
N/A
~50
I-START
2019
N/A
~50

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,300 Total Patients Enrolled
Linda Siminerio, RN, PhD, CDEPrincipal Investigator - Professor
University of Pittsburgh
4 Previous Clinical Trials
5,238 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Insulin Start Therapy Application With Resources and Training
Linda Siminerio 2019. "Insulin Start Therapy Application With Resources and Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999268.
~8 spots leftby Apr 2025
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