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Insulin
0% Bolus Insulin Correction for Type 1 Diabetes (FIT Trial)
Phase 4
Waitlist Available
Led By Ronnie Aronson, MD
Research Sponsored by LMC Diabetes & Endocrinology Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 147 days
Awards & highlights
FIT Trial Summary
The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting.
Eligible Conditions
- Type 1 Diabetes
FIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 147 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~147 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction In Plasma Glucose (YSI)
Secondary outcome measures
Investigate Glycemic Response of a 0%, 50%, 100% and 150% Bolus Insulin Correction of Post-exercise Hyperglycemia Compared to no Bolus Insulin Correction
FIT Trial Design
4Treatment groups
Active Control
Group I: 0% Bolus Insulin CorrectionActive Control1 Intervention
0% Bolus Insulin Correction
Group II: 50% Bolus Insulin CorrectionActive Control1 Intervention
50% Bolus Insulin Correction
Group III: 100% Bolus Insulin CorrectionActive Control1 Intervention
100% Bolus Insulin Correction
Group IV: 150% Bolus Insulin CorrectionActive Control1 Intervention
150% Bolus Insulin Correction
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Who is running the clinical trial?
LMC Diabetes & Endocrinology Ltd.Lead Sponsor
16 Previous Clinical Trials
22,865 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,962 Total Patients Enrolled
Ronnie Aronson, MDPrincipal InvestigatorLMC Diabetes & Endocrinology
7 Previous Clinical Trials
10,433 Total Patients Enrolled
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