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Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes

NCT05973422 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-11

No results posted yet for this study

Summary

This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.

Conditions

Interventions

DEVICE

SIGI Insulin Management System

Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Anne Wojtusciszyn, MD · CHUV Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-09-30
Completion
2024-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973422 on ClinicalTrials.gov