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:
NCT04620967
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes for ≥ 5 years
* HbA1c 53-75 mmol/mol (7.0-9.0%)
* Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
* CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
* Carbohydrate counting for all snacks and meals
* Use of the insulin pump bolus calculator for all meals and snacks
Exclusion Criteria:
* Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
* Gastroparesis (clinical assessment)
* Shift work
* Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
* Use of a hybrid closed-loop system
* Use of flash glucose monitoring
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Chronic paracetamol use
* Alcohol or drug abuse
* Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
* Impaired renal function (eGFR\< 60 ml/min/1.73 m2)
* History of local skin reactions to Fiasp and/or Iasp
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
* Lack of compliance with key study procedures at the discretion of the investigator
* Unacceptable adverse events at the discretion of the investigator
* Less than 40 weeks guarantee remaining on insulin pump
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04620967
Study Brief:
Protocol Section:
NCT04620967