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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT01787903
Eligibility Criteria:
Inclusion Criteria:
* T1DM, diagnosed according to ADA criteria regardless duration
* Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion
* Any HbA1c
* Age between 18 and 70 years old (inclusive)
* IHA according to the questionnaire by Gold et al.
* Performing at least 3 SMBG/day or 21 SMBG/week
Exclusion Criteria:
* Type 2 diabetes mellitus
* History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders)
* Current untreated proliferative diabetic retinopathy
* Current (treatment for) malignancy
* Current use of non-selective beta-blockers
* Current psychiatric disorders, including schizophrenia, bipolar disorder, anorexia nervosa or bulimia nervosa
* Substance abuse or alcohol abuse (men \>21 units/week, women \>14 units/week)
* Current pregnancy or intention to conceive
* Current use of RT-CGM other than for short term (i.e. diagnostic use or use shorter than 3 consecutive months)
* Hearing or vision impairment hindering perceiving of glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator
* Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding of the purpose and instructions of the study
* Participation in another clinical study
* Known or suspected allergy to trial product or related products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01787903
Study Brief:
Protocol Section:
NCT01787903