Need-driven Treatment of the Patients With Type 1 Diabetes

The primary outcome of this study is the proportion of patients who maintain good glycemic control during the 24-month follow-up period. A clinically significant result is defined as no more than 14% of patients (95% confidence interval: 8%-20%) experiencing deterioration in glucose control, indicated by Time in Range (TIR) < 70% or HbA1c > 53 mmol/mol. If at least 125 patients are enrolled, need-based care can be demonstrated to be safe.

The study also evaluates the performance and safety of the "MD Diabetes Huolijono" software application, which issues alerts to healthcare professionals if glucose control worsens or if the patient is hospitalized. Between visits, patients using a Libre sensor with multiple daily insulin injections will be monitored using the MD Diabetes Huolijono system, while other patients will continue standard self-monitoring.

Healthcare contact data will be retrieved from the data service for each participant for the 24 months prior to study enrollment and throughout the follow-up period.

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)