Clinical trial NCT05973422: Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
Official title: Sigi Insulin Management System - First-in-Human Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Insulin patch pump
CGM control
Smartphone control
Pre-filled insulin cartridges
Occlusion detection
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 15 days
measure: Adverse Events
timeFrame: 15 days
measure: Adverse Device Effects
timeFrame: 15 days
measure: Serious adverse device effects (SADE)
timeFrame: 15 days
Secondary outcomes:
measure: Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi
timeFrame: 15 days
measure: Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
timeFrame: 15 days
measure: Acceptance and confidence of PI to proceed to outpatient use
timeFrame: 1 day
measure: Acceptance and confidence of participant to proceed to outpatient use
timeFrame: 1 day
measure: Device deficiencies
timeFrame: 15 days
measure: Evaluation of pad duration (days)
timeFrame: 15 days
measure: Occlusion detection rate
timeFrame: 15 days
measure: Evaluation of skin tolerance
timeFrame: 15 days
measure: Evaluation of overall device tolerance
timeFrame: 15 days
measure: System Usability Scale (SUS) at baseline and 15 days for the PAD
timeFrame: 15 days
measure: System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: CHUV Centre Hospitalier Universitaire Vaudois
name: Anne Wojtusciszyn, MD
role: PRINCIPAL_INVESTIGATOR
References: