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Insulin

Untethered CSII for 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

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal 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

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 mins

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time in range within 6 hours

Secondary study objectives

Change in Diabetes Medication Satisfaction (DiabMedSat) Score

Hypoglycemia

Change in TRIM-D Score

+8 more

Side effects data

From 2023 Phase 4 trial • 60 Patients • NCT04538352

18%

Pain

Syncopal episode

Pneumonia

Vomiting

Colitis

Acute Kidney Injury

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Once-weekly sc Semaglutide Combined With Once-daily Insulin

MDI Requiring Multiple Daily Injections of Insulin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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