Type 1 DiabetesSigiFIHNCT05973422
Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
A study testing SIGI Insulin Management System in people with Type 1 Diabetes, run by Tandem Diabetes Care, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- SIGI Insulin Management System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- SIGI Insulin Management System
- Keywords
- Insulin patch pump, CGM control, Smartphone control, Pre-filled insulin cartridges, Occlusion detection
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIGI Insulin Management SystemDevice
Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.
| Study group | Role | What they receive |
|---|---|---|
| SIGI Insulin Management System Observed and At-Home Use | Experimental | 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. Receives: Device: SIGI Insulin Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Number of serious adverse events
Measured: 15 days
Adverse Events
Number of adverse events
Measured: 15 days
Adverse Device Effects
Number of adverse device effects (ADE)
Measured: 15 days
Serious adverse device effects (SADE)
Number of serious adverse device effects (ADE)
Measured: 15 days
Secondary outcomes (11)
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
Measured: 15 days
Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
Number of diabetic ketoacidosis events
Measured: 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.
Measured: 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.
Measured: 1 day
Device deficiencies
Number of device deficiencies (device issues) recorded during study use
Measured: 15 days
Evaluation of pad duration (days)
Collect pad replacement dates to calculate the pad survival rate at 3 days
Measured: 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)
Measured: 15 days
Evaluation of skin tolerance
Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start31 May 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Wojtusciszyn, MD, Principal investigator, CHUV Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973422
- Sponsor's protocol ID
- CIP-0001 Sigi FIH Study CIP
- Acronym
- SigiFIH
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sigi Insulin Management System - First-in-Human Study
- ClinicalTrials.gov ID
- NCT05973422
- Acronym / sponsor ID
- SigiFIH / CIP-0001 Sigi FIH Study CIP
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin patch pump, CGM control, Smartphone control, Pre-filled insulin cartridges, Occlusion detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIGI Insulin Management System Observed and At-Home Use | Experimental | Device: SIGI Insulin Management SystemCurrent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIGI Insulin Management SystemContinuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App. | Device | SIGI Insulin Management System Observed and At-Home Use |
Primary outcome
Serious Adverse Events
Time frame: 15 days
Number of serious adverse events
Adverse Events
Time frame: 15 days
Number of adverse events
Adverse Device Effects
Time frame: 15 days
Number of adverse device effects (ADE)
Serious adverse device effects (SADE)
Time frame: 15 days
Number of serious adverse device effects (ADE)
11 secondary outcomes
Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi
Time frame: 15 days
Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi
Time frame: 15 days
Acceptance and confidence of PI to proceed to outpatient use
Time frame: 1 day
Acceptance and confidence of participant to proceed to outpatient use
Time frame: 1 day
Device deficiencies
Time frame: 15 days
Evaluation of pad duration (days)
Time frame: 15 days
Occlusion detection rate
Time frame: 15 days
Evaluation of skin tolerance
Time frame: 15 days
Evaluation of overall device tolerance
Time frame: 15 days
System Usability Scale (SUS) at baseline and 15 days for the PAD
Time frame: 15 days
System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Wojtusciszyn, MD principal investigator
CHUV Centre Hospitalier Universitaire Vaudois
Questions about this trial
What is this clinical trial studying?
A study testing SIGI Insulin Management System in people with Type 1 Diabetes, run by Tandem Diabetes Care, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Woodtli (+41786032519, awoodtli@tandemdiabetes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.