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

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SIGI Insulin Management System
Sponsored by
Tandem Diabetes Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Type 1 Diabetes focused on measuring Insulin patch pump, CGM control, Smartphone control, Pre-filled insulin cartridges, Occlusion detection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SIGI Insulin Management System Observed and At-Home Use

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Serious Adverse Events
    Number of serious adverse events
    Adverse Events
    Number of adverse events
    Adverse Device Effects
    Number of adverse device effects (ADE)
    Serious adverse device effects (SADE)
    Number of serious adverse device effects (ADE)

    Secondary Outcome Measures

    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
    Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
    Number of diabetic ketoacidosis events
    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.
    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.
    Device deficiencies
    Number of device deficiencies (device issues) recorded during study use
    Evaluation of pad duration (days)
    Collect pad replacement dates to calculate the pad survival rate at 3 days
    Occlusion detection rate
    Rate of occlusions detected by the system over the total wear period (number of occlusions/total wear time in days)
    Evaluation of skin tolerance
    Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.
    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.
    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.
    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.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Tandem Diabetes Care, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05973422
    Brief Title
    Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
    Acronym
    SigiFIH
    Official Title
    Sigi Insulin Management System - First-in-Human Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tandem Diabetes Care, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Insulin patch pump, CGM control, Smartphone control, Pre-filled insulin cartridges, Occlusion detection

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SIGI Insulin Management System Observed and At-Home Use
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    SIGI Insulin Management System
    Intervention Description
    Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.
    Primary Outcome Measure Information:
    Title
    Serious Adverse Events
    Description
    Number of serious adverse events
    Time Frame
    15 days
    Title
    Adverse Events
    Description
    Number of adverse events
    Time Frame
    15 days
    Title
    Adverse Device Effects
    Description
    Number of adverse device effects (ADE)
    Time Frame
    15 days
    Title
    Serious adverse device effects (SADE)
    Description
    Number of serious adverse device effects (ADE)
    Time Frame
    15 days
    Secondary Outcome Measure Information:
    Title
    Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi
    Description
    Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
    Time Frame
    15 days
    Title
    Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
    Description
    Number of diabetic ketoacidosis events
    Time Frame
    15 days
    Title
    Acceptance and confidence of PI to proceed to outpatient use
    Description
    Number of participants who pass the observed use setting as evaluated by PI and proceed to outpatient use.
    Time Frame
    1 day
    Title
    Acceptance and confidence of participant to proceed to outpatient use
    Description
    Number of participants who pass the observed use setting as evaluated by participants and proceed to outpatient use.
    Time Frame
    1 day
    Title
    Device deficiencies
    Description
    Number of device deficiencies (device issues) recorded during study use
    Time Frame
    15 days
    Title
    Evaluation of pad duration (days)
    Description
    Collect pad replacement dates to calculate the pad survival rate at 3 days
    Time Frame
    15 days
    Title
    Occlusion detection rate
    Description
    Rate of occlusions detected by the system over the total wear period (number of occlusions/total wear time in days)
    Time Frame
    15 days
    Title
    Evaluation of skin tolerance
    Description
    Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.
    Time Frame
    15 days
    Title
    Evaluation of overall device tolerance
    Description
    Number of reports related to discomfort at the infusion site, including discomfort related adverse events, during the 15 day wear time.
    Time Frame
    15 days
    Title
    System Usability Scale (SUS) at baseline and 15 days for the PAD
    Description
    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.
    Time Frame
    15 days
    Title
    System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly
    Description
    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.
    Time Frame
    15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alain Woodtli
    Phone
    +41786032519
    Email
    awoodtli@tandemdiabetes.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laetitia Galea
    Phone
    +41215523676
    Email
    lgalea@tandemdiabetes.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Wojtusciszyn, MD
    Organizational Affiliation
    CHUV Centre Hospitalier Universitaire Vaudois
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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