Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT07031492
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-60 years inclusive.
* T1D as per the American Diabetes Association classification for \>12 months prior to the screening visit.
* Minimed 780G®-hybrid closed-loop system users for at least 6 months. Use of automatic mode (Smartguard) \> 80% of the time.
* A1c level below 9.0% at Screening visit.
* Assessment of albuminuria and retinal tests, which should have yielded negative results for advanced medical complications.
* Willing and able to adhere to the study protocol
Exclusion Criteria:
* Not having met the previous criteria for inclusion.
* Females who are pregnant or intend to become pregnant during the study period; a positive pregnancy test at screening will result in exclusion.
* Breastfeeding.
* Use of any non-insulin glucose-lowering therapy within three months prior to study initiation.
* Presence of moderate/severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m².
* History of severe hypoglycemia (defined as coma or convulsion requiring assistance from others) or diabetic ketoacidosis in the six months prior to study initiation.
* Hypoglycemia unawareness (defined as Clarke Test score greater than 3).
* Occurrence of an acute cardiovascular event (e.g., myocardial infarction, unstable angina, stroke) within twelve months prior to study initiation.
* History of drug or alcohol abuse. History of any active or suspected malignancy.
* Clinically significant microvascular complications (such as macroalbuminuria, preproliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results.
* Diabetic gastroparesis.
* Scheduled surgery during the study period.
* Adherence to a very low carbohydrate diet, defined as a carbohydrate intake of less than 40 grams per day.
* Presence of any comorbid medical or psychological condition deemed by the investigators to render the individual unsuitable for study participation.
* Known allergy to insulin NovoRapid.
* Regular practice of competitive or very high intensity physical activity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07031492
Study Brief:
Protocol Section:
NCT07031492