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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT07128992
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of type 1 diabetes
* Treatment with multiple daily injections or insulin pump therapy
* Duration of diabetes ≥ 1 year
* Good glycemic control over the previous two weeks, defined as:
* HbA1c \< 53 mmol/mol
* Time in Range (TIR) \> 70%
* Time Below Range (TBR) \< 4%
* Time Above Range (TAR) \< 25%
* Use of a continuous glucose monitoring system connected via a smartphone application
* Under specialist diabetes care within the Pirkanmaa Wellbeing Services County (Pirha)
* Willing to accept remote diabetes care by granting the diabetes team at Tampere University Hospital access to glucose data
* No need for regular specialist care due to other medical conditions
* Provides informed consent to participate in the study
Exclusion Criteria:
* Age \< 18 years
* Duration of diabetes \< 1 year
* Pregnancy
* Not using multiple daily injections or insulin pump therapy
* Not using a continuous glucose monitoring system
* Does not accept remote care
* History of diabetic ketoacidosis or severe hypoglycemia within the past 12 months
* Presence of retinopathy
* No retinal imaging performed within the past 12 months
* Urine albumin-creatinine ratio (uACR) \> 3 mg/mmol or estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² on two occasions over a period of more than 3 months
* Undergoing dialysis or post-kidney transplantation
* Cardiovascular disease (excluding hypertension)
* Neuropathy, foot ulcer, or amputation (foot risk category 1-3)
* Scheduled hospital outpatient visits for other specialties within the next 12 months
* Not under specialist diabetes care within the Pirkanmaa Wellbeing Services County (Pirha)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07128992
Study Brief:
Protocol Section:
NCT07128992