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

Sigi Insulin Management System - First-in-Human Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: SIGI Insulin Management System

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Woodtli; Phone Number: +41786032519; Email: awoodtli@tandemdiabetes.com
• Study Contact Backup: Name: Laetitia Galea; Phone Number: +41215523676; Email: lgalea@tandemdiabetes.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: SIGI Insulin Management System; Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Investigators: Principal Investigator: Anne Wojtusciszyn, MD, CHUV Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Insulin patch pump; CGM control; Smartphone control; Pre-filled insulin cartridges; Occlusion detection
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CIP-0001 Sigi FIH Study CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No