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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sigi Insulin Management System - First-in-Human Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: SIGI Insulin Management System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIGI Insulin Management System Observed and At-Home Use<br>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. | Device: SIGI Insulin Management System<br>* Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Number of serious adverse events | 15 days | 
| Adverse Events | Number of adverse events | 15 days | 
| Adverse Device Effects | Number of adverse device effects (ADE) | 15 days | 
| Serious adverse device effects (SADE) | Number of serious adverse device effects (ADE) | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study | 15 days | 
| Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi | Number of diabetic ketoacidosis events | 15 days | 
| Acceptance and confidence of PI to proceed to outpatient use | Number of participants who pass the observed use setting as evaluated by PI and proceed to outpatient use. | 1 day | 
| Acceptance and confidence of participant to proceed to outpatient use | Number of participants who pass the observed use setting as evaluated by participants and proceed to outpatient use. | 1 day | 
| Device deficiencies | Number of device deficiencies (device issues) recorded during study use | 15 days | 
| Evaluation of pad duration (days) | Collect pad replacement dates to calculate the pad survival rate at 3 days | 15 days | 
| Occlusion detection rate | Rate of occlusions detected by the system over the total wear period (number of occlusions/total wear time in days) | 15 days | 
| Evaluation of skin tolerance | Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time. | 15 days | 
| Evaluation of overall device tolerance | Number of reports related to discomfort at the infusion site, including discomfort related adverse events, during the 15 day wear time. | 15 days | 
| System Usability Scale (SUS) at baseline and 15 days for the PAD | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the PAD. | 15 days | 
| System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability, collected at baseline and 15 days for evaluation of the pump assembly. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin patch pump, CGM control, Smartphone control, Pre-filled insulin cartridges, Occlusion detection