Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
New artificial pancreas system tested with ultrarapid insulin for Type 1 Diabetes
Plain English Summary
Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes is a Not Applicable clinical trial sponsored by Inreda Diabetic B.V. studying Type 1 Diabetes. This trial tests a new artificial pancreas system that uses an ultrarapid insulin (Lyumjev) to automatically control blood sugar levels in people with Type 1 Diabetes. It is for adults (18-75 years old) with Type 1 Diabetes who are already using an artificial pancreas system. Participants will use the system with two different types of insulin (Lyumjev and Humalog) for about a month each, switching between them. Alternatives include standard insulin therapy, continuous glucose monitoring with manual insulin adjustments, or existing artificial pancreas systems. The trial aims to enroll 12 participants.
Official Summary
The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. In addition, safety parameters, pharmacodynamics and AP-related parameters will be acquired. This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects. The subjects will be randomized to receive either Lyumjev or Humalog® for a 30-day study period and will then switch to the alternate insulin treatment after a wash-out period.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have Type 1 Diabetes and have been using an artificial pancreas for at least a month. You must be between 18 and 75 years old and able to give informed consent. You cannot join if you have trouble recognizing low blood sugar, are pregnant or breastfeeding, or have certain other medical conditions. You also cannot join if you are using certain medications like acetaminophen, which can affect glucose readings. This trial is studying Type 1 Diabetes, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see how much time the artificial pancreas system keeps blood sugar levels within a healthy range, meaning it's working effectively to prevent highs. The specific primary outcome measures are: Percentage of Time the Glucose Level is Above 10 mmol/l (25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores a more automated way to manage blood sugar for people with Type 1 Diabetes, potentially improving daily life and reducing the burden of constant monitoring and a This research targets Type 1 Diabetes, where improved treatment options are needed.
Investor Insight
This trial signals innovation in diabetes management technology, with potential for improved patient outcomes and a growing market for advanced artificial pancreas systems.
Is This Trial Right for Me?
Ask your doctor if this new system and ultrarapid insulin are suitable for your specific diabetes management needs. Be prepared to use the artificial pancreas system with two different insulins for approximately two months, with regular monitoring. Understand that this is an open-label study, meaning both you and the researchers will know which treatment you are receiving. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: NONE
- Enrollment: 12 participants
Interventions
- DRUG: Insulin Lispro Cartridge [Lyumjev] — Administration of Lyumjev in combination with the AP system
- DRUG: Insulin Lispro Cartridge — Administration of Humalog in combination with the AP system (standard therapy)
Primary Outcomes
- Percentage of Time the Glucose Level is Above 10 mmol/l (25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired)
Secondary Outcomes
- Side Effects of Insulin (68 days (whole study period))
- Pharmacodynamic Parameters: Euglycemia (25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Hypoglycemia (25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Mean Glucose Value (25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Standard Deviation of Glucose Value (25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
Full Eligibility Criteria
Inclusion Criteria: * Diagnosed with diabetes mellitus type 1; * Treated with the Inreda AP system for a minimum of 1 month; * Age between 18 and 75 years; * Willing and able to sign informed consent. Since subjects are treated with the Inreda AP, the following inclusion criteria will be met: * Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months; * HbA1c \< 97 mmol/mol; * BMI \< 35 kg/m\^2; * No use of acetaminophen, as this may influence the sensor glucose measurements. Exclusion Criteria: * Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire; * Pregnancy and/or breastfeeding; * Use of oral antidiabetic agents; * Insulinoma; * Hypersensitivity reactions to Lyumjev or any of the excipients.
Trial Locations
- Rijnstate Hospital, Arnhem, Gelderland, Netherlands
- Slingeland Hospital, Doetinchem, Gelderland, Netherlands
- Hospital Gelderse Vallei, Ede, Gelderland, Netherlands
Frequently Asked Questions
What is clinical trial NCT05508061?
NCT05508061 is a Not Applicable INTERVENTIONAL study titled "Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes." It is currently completed and is sponsored by Inreda Diabetic B.V.. The trial targets enrollment of 12 participants.
What conditions does NCT05508061 study?
This trial investigates treatments for Type 1 Diabetes. The primary condition under study is Type 1 Diabetes.
What treatments are being tested in NCT05508061?
The interventions being studied include: Insulin Lispro Cartridge [Lyumjev] (DRUG), Insulin Lispro Cartridge (DRUG). Administration of Lyumjev in combination with the AP system
What does Not Applicable mean for NCT05508061?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05508061?
This trial is currently "Completed." It started on 2022-10-19. The estimated completion date is 2023-03-16.
Who is sponsoring NCT05508061?
NCT05508061 is sponsored by Inreda Diabetic B.V.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05508061?
The trial aims to enroll 12 participants. The trial status is completed.
How is NCT05508061 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs none masking.
What are the primary outcomes being measured in NCT05508061?
The primary outcome measures are: Percentage of Time the Glucose Level is Above 10 mmol/l (25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05508061 being conducted?
This trial is being conducted at 3 sites, including Arnhem, Gelderland; Doetinchem, Gelderland; Ede, Gelderland (Netherlands).
Where can I find official information about NCT05508061?
The official record for NCT05508061 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05508061. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05508061 testing in simple terms?
This trial tests a new artificial pancreas system that uses an ultrarapid insulin (Lyumjev) to automatically control blood sugar levels in people with Type 1 Diabetes. It is for adults (18-75 years old) with Type 1 Diabetes who are already using an artificial pancreas system.
Why is this trial significant?
This trial matters because it explores a more automated way to manage blood sugar for people with Type 1 Diabetes, potentially improving daily life and reducing the burden of constant monitoring and a
What are the potential risks of participating in NCT05508061?
The main risks are related to the artificial pancreas system and insulin, including potential for very low blood sugar (hypoglycemia) or very high blood sugar (hyperglycemia) if the system malfunctions. Side effects could include reactions at the insulin injection site or issues with the continuous glucose monitor. There's also a risk of allergic reactions to the insulins used. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05508061?
Ask your doctor if this new system and ultrarapid insulin are suitable for your specific diabetes management needs. Be prepared to use the artificial pancreas system with two different insulins for approximately two months, with regular monitoring. Understand that this is an open-label study, meaning both you and the researchers will know which treatment you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05508061 signal from an investment perspective?
This trial signals innovation in diabetes management technology, with potential for improved patient outcomes and a growing market for advanced artificial pancreas systems. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use the system with two different types of insulin (Lyumjev and Humalog) for about a month each, switching between them. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.