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

Tandem Diabetes Care

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Device: SIGI Insulin Management System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05973422

CIP-0001 Sigi FIH Study CIP

Details and patient eligibility

About

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.

Full description

Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous delivery if insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Sigi is offering superior delivery accuracy and precision, accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and smartphone control.

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent signed
• 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 T2D
• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SIGI Insulin Management System Observed and At-Home Use

Experimental group

Description:

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.

Treatment:

Device: SIGI Insulin Management System