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

Type 1 Diabetes Clinical Trial

— SigiFIH  

Official title:

Sigi Insulin Management System - First-in-Human Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973422
• Other study ID #: CIP-0001 Sigi FIH Study CIP
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Tandem Diabetes Care, Inc.
• Contact: Alain Woodtli
• Phone: +41786032519
• Email: awoodtli[@]tandemdiabetes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• SIGI Insulin Management System
Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	Number of serious adverse events	15 days
Primary	Adverse Events	Number of adverse events	15 days
Primary	Adverse Device Effects	Number of adverse device effects (ADE)	15 days
Primary	Serious adverse device effects (SADE)	Number of serious adverse device effects (ADE)	15 days
Secondary	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
Secondary	Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi	Number of diabetic ketoacidosis events	15 days
Secondary	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
Secondary	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
Secondary	Device deficiencies	Number of device deficiencies (device issues) recorded during study use	15 days
Secondary	Evaluation of pad duration (days)	Collect pad replacement dates to calculate the pad survival rate at 3 days	15 days
Secondary	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
Secondary	Evaluation of skin tolerance	Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.	15 days
Secondary	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
Secondary	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
Secondary	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