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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes
• Interventions: Device: SIGI Insulin Management System

• Registration Number: NCT05973422
• Lead Sponsor: Tandem Diabetes Care, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Study Start: 2024-05-31
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIGI Insulin Management System Observed and At-Home Use	SIGI Insulin Management System	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.

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	15 days	Number of serious adverse events
Adverse Device Effects	15 days	Number of adverse device effects (ADE)
Serious adverse device effects (SADE)	15 days	Number of serious adverse device effects (ADE)
Adverse Events	15 days	Number of adverse events

Secondary Outcome Measures

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