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

• ClinicalTrials.gov Identifier: NCT05973422
• Recruitment Status: Not yet recruiting
• First Posted: August 2, 2023
• Last Update Posted: January 11, 2024
• Sponsor: Tandem Diabetes Care, Inc.
• Information provided by (Responsible Party): Tandem Diabetes Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Device: SIGI Insulin Management System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Sigi Insulin Management System - First-in-Human Study
• Estimated Study Start Date: May 31, 2024
• Estimated Primary Completion Date: September 30, 2024
• Estimated Study Completion Date: September 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Serious Adverse Events [ Time Frame: 15 days ]
   Number of serious adverse events
2. Adverse Events [ Time Frame: 15 days ]
   Number of adverse events
3. Adverse Device Effects [ Time Frame: 15 days ]
   Number of adverse device effects (ADE)
4. Serious adverse device effects (SADE) [ Time Frame: 15 days ]
   Number of serious adverse device effects (ADE)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Alain Woodtli; +41786032519; awoodtli@tandemdiabetes.com

Contact: Laetitia Galea; +41215523676; lgalea@tandemdiabetes.com

Sponsors and Collaborators

Tandem Diabetes Care, Inc.

Investigators

• Principal Investigator: Anne Wojtusciszyn, MD; CHUV Centre Hospitalier Universitaire Vaudois

More Information

• Responsible Party: Tandem Diabetes Care, Inc.
• ClinicalTrials.gov Identifier: NCT05973422
• Other Study ID Numbers: CIP-0001 Sigi FIH Study CIP
• First Posted: August 2, 2023
• Last Update Posted: January 11, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tandem Diabetes Care, Inc.:

Insulin patch pump; CGM control; Smartphone control; Pre-filled insulin cartridges; Occlusion detection

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs