Official Title
Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Adults With Type 1 Diabetes: EVOLUTION T1D
Brief Summary

Single-arm feasibility study to evaluate the safety and feasibility of the Omnipod MSystem in adults with type 1 diabetes. This study will enroll up to 40 adult participantsto have a minimum of 24 participants to initiate the use of the study device. The studywill include hotel and outpatient evaluation periods.

Detailed Description

Not Provided

Not yet recruiting
Type 1 Diabetes
Type 1 Diabetes Mellitus
Diabetes (DM)

Device: Omnipod M System

Participants will use the Omnipod M System

Eligibility Criteria

Inclusion Criteria:

- Age at time of consent 16-70 years (inclusive)

- Type 1 diabetes diagnosis for at least 6 months, based on Investigator assessment

- Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or
without automation

- Willing to use the following types of U-100 insulin during the study: Humalog U-100,
Novorapid or their generic equivalents

- Deemed appropriate for pump therapy per Investigator's assessment considering
previous history of severe hypoglycemic and hyperglycemic events, and other
comorbidities

- If using noninsulin glucose-lowering medications or weight reduction medications,
dose has been stable for 6-weeks prior to screening; and participant is willing to
not change the dose unless required for safety purposes.

- Investigator has confidence that the participant can safely operate all study
devices and can adhere to the protocol

- Willing to wear the system continuously throughout the study

- Willing and able to sign the Informed Consent Form (ICF)

- Able to read and understand English

- If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

- Any medical condition, which in the opinion of the Investigator, would put the
participant at an unacceptable safety risk. This may include untreated malignancy,
unstable cardiac disease, unstable or end-stage renal disease, unstable
proliferative retinopathy, unstable psychiatric conditions such as eating disorders,
drug or alcohol abuse.

- Current or known history of coronary artery disease that is not stable with medical
management, including unstable angina, or a history of myocardial infarction,
percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias
requiring intervention within the 12 months prior to screening

- Any planned surgery during the study which could be considered major in the opinion
of the Investigator

- History of more than 1 severe hypoglycaemia in the past 6 months. Severe
hypoglycaemia is defined as an event that requires the assistance of another person
due to altered consciousness, and requires another person to actively administer
carbohydrate, glucagon, or other resuscitative actions

- History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic
state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked,
dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate
adhesive tape or has any unresolved skin condition that could impact sensor or pump
placement

- Blood disorder or dyscrasia within 3 months prior to screening, which in the
Investigator's opinion could interfere with determination of HbA1c

- Use of hydroxyurea

- Plans to receive blood transfusion over the course of the study

- Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a
local steroid injection (intraarticular, epidural) within 1 week prior to screening
or plans to take oral or injectable steroids during the study

- Use of non-insulin glucose-lowering medication or weight loss medications other than
metformin and/or GLP1, in the 4 weeks prior to screening. Participants taking
metformin and/or GLP1 should remain on a steady dose without dose increases during
study participation

- Pregnant or lactating, or is of childbearing potential and not using an acceptable
form of birth control (acceptable forms of contraception include abstinence, barrier
methods such as condoms, hormonal contraceptives, intrauterine device, surgical
sterilisation such as tubal ligation or hysterectomy, or vasectomised partner);
childbearing potential means that menstruation has started, and the participant is
not surgically sterile or greater than 12 months post-menopausal).

- In the past 30-days, has participated in a clinical study using any investigational
drug or any investigational device. Additionally, may not intend to participate in
any other interventional clinical study during this study period

- Unable to follow clinical protocol for the duration of the study or is otherwise
deemed unacceptable to participate in the study per the Investigator's clinical
judgment

- Participant is an employee of Insulet, an Investigator or a member of Investigator's
study team, or immediate family member of any of the aforementioned

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 70 Years
Countries
New Zealand
Locations

University of Otago
Christchurch, New Zealand

Investigator: Mercedes Burnside, MD
mercedes@edgetrials.co.nz

Investigator: Martin deBock, FRACP, PHD

Contacts

Trang Ly, MBBS, PhD
978-600-7000
APClinical@insulet.com

Bonnie Dumais, RN
978-600-7000
APClinical@insulet.com

Not Provided

Insulet Corporation
NCT Number
Keywords
Type 1 Diabetes
T1D
Omnipod
Omnipod M
Automated Insulin Delivery System
AID
fully closed loop
FCL
MeSH Terms
Diabetes Mellitus, Type 1
Diabetes Mellitus