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Study on Insulin Glargine for Patients with Type 2 Diabetes: Comparing Decentralized, Hybrid, and Standard Clinical Trial Approaches

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 diabetes mellitus, a condition where the body struggles to manage blood sugar levels effectively. The treatment being tested in this study is called Toujeo, which is a form of insulin known as insulin glargine. It is administered as a solution for injection using a pre-filled pen. The purpose of the study is to explore the benefits and acceptability of using technology-centered approaches, known as decentralised and hybrid clinical trials, compared to traditional trials conducted in hospitals or research centers.

Participants in the study will be individuals who have been diagnosed with Type 2 diabetes mellitus for at least one year and are already using a type of insulin as part of their treatment. The study will last for a period of 24 weeks, during which participants will continue their usual insulin treatment while being monitored. The trial will compare different ways of conducting clinical trials, including those that use technology to allow more flexibility and convenience for participants, such as remote data entry and video conferencing.

The study aims to assess various aspects such as how quickly participants can be enrolled, how many complete the study, and the diversity of participants. It will also look at how well participants adhere to their insulin treatment and the quality of data collected. Additionally, the study will measure changes in blood sugar levels, specifically looking at HbA1c and fasting blood sugar levels, to determine the effectiveness of the treatment over the course of the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide a signed written informed consent or e-consent, depending on the study group you are assigned to.
You must have been diagnosed with type 2 diabetes mellitus for at least one year and have been treated with a basal insulin for at least three months prior to joining the study.
Step 2
Initial assessment
An initial assessment will be conducted to ensure your daily basal insulin dose has been stable for at least one month before the study begins.
Your mental and physical status will be evaluated to confirm your ability to perform daily activities, including administering injectable insulin and measuring blood sugar levels.
Step 3
Medication administration
You will be using Toujeo 300 units/ml SoloStar, a solution for injection in a pre-filled pen, administered via subcutaneous injection.
The dosage and frequency of the insulin administration will be determined by the study protocol and your healthcare provider.
Step 4
Data collection
You will be required to use a tablet or smartphone with Bluetooth functionality and have access to an internet connection for remote data entry.
For part B of the study, video conferencing may be necessary to facilitate data collection and communication.
Step 5
Home visits
If you are part of Part A of the study, you must be willing and able to permit home visits for data collection and monitoring purposes.
Step 6
Study duration
The study is expected to continue until August 21, 2024, with regular assessments and data collection throughout this period.
Your participation will involve adherence to the study drug receipt, accountability, and return processes and procedures.
Step 7
End of study
Upon completion of the study, your data will be analyzed to assess the potential benefits of the decentralized clinical trial approach.
The study aims to evaluate participant recruitment, retention, diversity, site and participant satisfaction, and cost-effectiveness.

Who can join the trial?

9 criteria

Participant with Type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit.
Participant treated with a basal insulin (a type of insulin given at a steady level) for at least 3 months before the screening visit.
The total daily basal insulin dose should be stable (within ±20%) for at least 1 month before the screening visit.
Signed written informed consent or e-consent, depending on the study group.
Participant's mental and physical status allows them to perform daily activities with no or minimal assistance, including the ability to give themselves insulin injections and check their blood sugar levels.
Willing and able to allow home visits (only for Part A of the study).
Willing and able to follow study procedures for receiving, using, and returning the study medication.
Access to a tablet or smartphone with Bluetooth functionality.
Access to an internet connection that allows remote data entry and, for part B, video conferencing.

Who cannot join the trial?

10 criteria

Patients with any other serious medical conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to the study medication.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse.
Patients with uncontrolled high blood pressure.
Patients with severe kidney or liver disease.
Patients with a history of heart disease or stroke.
Patients who are currently taking medications that could interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Futuremeds Łódź
Responsive
Lodz, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Responsive
Cracow, Poland

Trial locations

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Investigated drugs

Toujeo® is a long-acting insulin used to help control blood sugar levels in people with Type 2 diabetes. It works by providing a steady amount of insulin throughout the day, which helps to keep blood sugar levels stable. This medication is typically used once a day and is part of a broader diabetes management plan that may include diet, exercise, and other diabetes medications. In this clinical trial, Toujeo® is being used to compare different ways of conducting clinical trials, focusing on how these methods affect patient recruitment, retention, and satisfaction.

Insulin Glargine

What is already known about the treatment

Toujeo® – Toujeo® is administered as an injection under the skin, typically using a pre-filled pen device. It is currently recognized in medical literature as a long-acting insulin used to manage blood sugar levels in individuals with Type 2 diabetes mellitus. The main therapeutic indication for Toujeo® is to help control high blood sugar in adults with Type 2 diabetes. At the molecular level, Toujeo® works by mimicking the action of natural insulin, helping cells absorb glucose from the blood, thereby lowering blood sugar levels. It is classified pharmacologically as a long-acting insulin analog.

Investigated diseases

Type 2 diabetes mellitus – Type 2 diabetes mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Management of blood sugar levels is crucial to prevent further progression and complications.