NCT05973422

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

July 25, 2023

Last Update Submit

January 9, 2024

Conditions

Type 1 Diabetes

Keywords

Insulin patch pumpCGM controlSmartphone controlPre-filled insulin cartridgesOcclusion detection

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (11)

  • Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi

    15 days

  • Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi

    15 days

  • Acceptance and confidence of PI to proceed to outpatient use

    1 day

  • Acceptance and confidence of participant to proceed to outpatient use

    1 day

  • Device deficiencies

    15 days

  • +6 more secondary outcomes

Study Arms (1)

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.

Device: SIGI Insulin Management System

Interventions

SIGI Insulin Management SystemDEVICE

Continuous subcutaneous insulin infusion with Sigi, and wearing the Dexcom G7 sensor using the Dexcom App.

SIGI Insulin Management System Observed and At-Home Use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anne Wojtusciszyn, MD

    CHUV Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Woodtli

CONTACT

+41786032519awoodtli@tandemdiabetes.com

Laetitia Galea

CONTACT

+41215523676lgalea@tandemdiabetes.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

May 31, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share