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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02092051
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes
* Adults 18 years or older
* Written Informed Consent
* HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard)
Exclusion Criteria:
* Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
* Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
* Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the DexComG4. However, other pain killers can be used throughout the study duration.
* Current CGM use. (within the past 4 months
* History of allergic reaction to any of the CGMS materials or adhesives in contact with the skin.
* History of allergic reaction to chlorhexidine or alcohol antiseptic solution.
* Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
* Patient is uncomfortable by using the sensor during the blinded run-in period and believes it is unlikely that he/she will use the sensor more than 80% of the time during the trial.
* The patient has on average performed 12 or less calibrations per week during the run-in period.
* Insulin pump therapy=Continuous subcutaneous insulin infusion (CSII)
* Diabetes duration \< 1 year
* Participation in another study.
* Fasting C-peptide level of 0.3 nmol/l or higher
* eGFR \< 30 ml/min (estimated from creatinine, age and sex at the inclusion visit by the MDRD-formula)
* Planned house move during the next 1.5 years, making it difficult to come to study visits
* Other investigator-determined criteria making patients unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02092051
Study Brief:
Protocol Section:
NCT02092051