Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
NCT ID: NCT05973422
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2024-05-31
2024-09-30
Brief Summary
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Detailed Description
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Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical team during the whole study.
Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV) in Switzerland.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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SIGI Insulin Management System Observed and At-Home Use
Current insulin pump users with type 1 diabetes, age 18+, will use the SIGI insulin management system for 1 day observed in the hospital setting, then for 2 more weeks of outpatient use.
SIGI Insulin Management System
Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.
Interventions
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SIGI Insulin Management System
Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.
Eligibility Criteria
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Inclusion Criteria
* Patients with T1D since more than 1 year
* Adults 18+years
* Patients under sensor augmented pump for at least 6 months
* Hybrid closed-loop users willing to switch to manual mode 15 days before study
* Patients with calculated insulin-to-carb ratio and correction factor
* Patients with total daily insulin above 30 insulin units
* Patients with correction factor below 3.5 mmol/L
* No severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months
* Active users of Teflon infusion sets
* Patients willing to use a smartphone interface to use their pump and to answer study questionnaires
Exclusion Criteria
* Patients with T1D under multiple daily injections
* Patients using Apidra and not willing to switch to NovoRapid / Fiasp / Humalog
* Patients with history of skin diseases (e.g. generalized eczema, plan lichen, psoriasis)
* Patients with known allergy to some insulins
* Clarke's score ≥ 4 (hypoglycemia unawareness)
* Severe late complications of diabetes, like severe neuropathy, non-stabilized proliferative retinopathy, EGF \< 30 mL/min, myocardial infarction or stroke within the last 3 months
* Glycated hemoglobin HbA1c \> 8.5 % at screening visit
* Medications interacting with glucose homeostasis (e.g. steroids)
* Pregnant of breastfeeding women
* Planned operation / MRI / CT requiring removal of infusion pad over the 15 days of the study
* Planned travel over the 15 days of the study
* Persons under guardianship or incapable of judgement
18 Years
ALL
No
Sponsors
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Tandem Diabetes Care, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Wojtusciszyn, MD
Role: PRINCIPAL_INVESTIGATOR
CHUV Centre Hospitalier Universitaire Vaudois
Central Contacts
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Other Identifiers
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CIP-0001 Sigi FIH Study CIP
Identifier Type: -
Identifier Source: org_study_id
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