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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05458167
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent.
* Ability to understand, speak and read Danish fluently.
* Diagnosis of type 1 diabetes mellitus for ≥12 months.
* Age between ≥18 and \<60 years.
* Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.
* Body mass index (BMI) between ≥18.5 and \<30 kg/m2.
* Ability to use an Apple® (iOS version 13 and up) or Android® (Android version 8.0 and up) smartphone.
* Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months.
* Patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment).
* If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception.
Exclusion Criteria:
* Already using Hedia Diabetes Assistant.
* Use of human insulin or premixed insulin.
* Blood pressure \> 180/105 mmHg.
* Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.
* Job situation entailing night shifts.
* Fever.
* A mental state impeding compliance with the protocol.
* Expected non-compliance with the protocol at the discretion of the principal investigator.
* Pregnancy.
* Breast-feeding.
* Dialysis therapy or eGFR \< 60 ml/min.
* Patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke.
* Patients prescribed with beta blockers.
* Abuse of alcohol or drugs in the past two years.
* On-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment).
* Surgery scheduled for the study duration period.
* An episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months.
* Known gastroparesis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05458167
Study Brief:
Protocol Section:
NCT05458167