Status:
NOT_YET_RECRUITING
Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
Lead Sponsor:
Tandem Diabetes Care, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05973422
Start Date
May 31 2024
End Date
September 30 2024
Last Update
January 11 2024
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