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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIGI Insulin Management System | Device | Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Number of serious adverse events | 15 days |
| Adverse Events | Number of adverse events | 15 days |
| Adverse Device Effects | Number of adverse device effects (ADE) | 15 days |
| Serious adverse device effects (SADE) | Number of serious adverse device effects (ADE) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Woodtli | Contact | +41786032519 | awoodtli@tandemdiabetes.com | |
| Laetitia Galea | Contact | +41215523676 | lgalea@tandemdiabetes.com |
| Name | Affiliation | Role |
|---|---|---|
| Anne Wojtusciszyn, MD | CHUV Centre Hospitalier Universitaire Vaudois | Principal Investigator |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Number of diabetic ketoacidosis events |
| 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. | 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. | 1 day |
| Device deficiencies | Number of device deficiencies (device issues) recorded during study use | 15 days |
| Evaluation of pad duration (days) | Collect pad replacement dates to calculate the pad survival rate at 3 days | 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) | 15 days |
| Evaluation of skin tolerance | Number of recorded skin reactions, including skin related adverse events, during the 15 day wear time. | 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. | 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. | 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. | 15 days |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |