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Insulin

Untethered CSII for Type 1 Diabetes (FIT Untethered Trial)

Phase 4
Waitlist Available
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 120 mins
Awards & highlights

FIT Untethered Trial Summary

The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.

Eligible Conditions
  • Type 1 Diabetes

FIT Untethered Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 mins
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 mins for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in range within 6 hours
Secondary outcome measures
Change in Diabetes Medication Satisfaction (DiabMedSat) Score
Hypoglycemia
Change in TRIM-D Score
+8 more

Side effects data

From 2016 Phase 4 trial • 12 Patients • NCT02680457
25%
Mild hypoglycemia
8%
Lower limb paresthesias
8%
Flatulence
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin Degludec
Insulin Glargine

FIT Untethered Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Untethered CSIIExperimental Treatment1 Intervention
Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose
Group II: Usual CSIIActive Control1 Intervention
Continue to use the established CSII insulin therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin degludec
FDA approved

Find a Location

Who is running the clinical trial?

LMC Diabetes & Endocrinology Ltd.Lead Sponsor
16 Previous Clinical Trials
22,853 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
Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered
Ronnie Aronson, MD 2018. "Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03838783.
All > Type 1 Diabetes
~4 spots leftby Apr 2025
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