Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes (NCT03212950) | Clinical Trial Compass
CompletedNot Applicable
Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes
Slovenia20 participantsStarted 2017-07-10
Plain-language summary
A randomized, double-blinded (for insulin type), single centre, crossover design young adult study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency number EMEA/H/C/004046) or normal acting insulin Aspart.
Study duration will be about 3 weeks per subject, 5 month overall.
The objectives of this clinical investigation is:
1\. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity and unannounced meals, in a controlled in-hospital environment.
Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till 18:00 next day based on sensor glucose readings.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment
. Documented evidence should exist within the patient history of T1D
. The subject is between 18 and 25 years of age (inclusive) at the time of enrolment
. The subject has been treated with an insulin pump for at least 3 months
. The subject has an A1C value ≤ 9% based on analysis from the local laboratory at the time of enrolment
. The subject is willing to follow all study instructions
. Subject is available for the entire study duration and follow-up visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time within range 3.9 - 10 mmol/l (70 - 180 mg/dl)
Timeframe: 28 hours
Trial details
NCT IDNCT03212950
SponsorUniversity of Ljubljana, Faculty of Medicine
. Subject is willing to perform daily self-monitoring of blood glucose (SMBG) and required sensor calibrations
Exclusion criteria
. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder)
. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study. Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids.
. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening (Visit 1).
. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.
. Subject has current or recent history of alcohol or drug abuse.