NCT07128992Not yet recruiting
Need-driven Treatment of the Patients With Type 1 Diabetes
The Impact of Need-driven Treatment of Insulin-Deficient Diabetes on the Care Events, Glycemic Control, Risk Factors, and Complications in the Pirkanmaa Wellbeing Services County, Finland
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This prospective study evaluates the safety of extending the interval of routine calendar-based follow-up visits from every 12 months to every 24 months in patients with type 1 diabetes who are in good glycemic control and suitable for remote monitoring. The primary outcome is the proportion of patients who maintain good glycemic control during the 24-month follow-up period. Participants will attend two in-person visits at baseline (month 0) and at the end of follow-up (month 24), which include a comprehensive clinical examination, assessment of glucose control, and laboratory testing. One remote contact will occur at month 12 for prescription renewal and review of glucose data. Patients may contact their care unit as needed throughout the study. At the baseline and final visits, participants will complete a questionnaire assessing their perceived ability to manage self-care, the safety of the care plan, and their ability to contact their care provider when necessary.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 125 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 6 Oct 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Tampere University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT07128992
What you commit to
- Study type: Observational
- Planned participants: 125
- From 6 Oct 2025 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not using multiple daily injections or insulin pump therapy
- Undergoing dialysis or post-kidney transplantation
Other illness
- Duration of diabetes \< 1 year
- History of diabetic ketoacidosis or severe hypoglycemia within the past 12 months
- Cardiovascular disease (excluding hypertension)
- Neuropathy, foot ulcer, or amputation (foot risk category 1-3)
- Not under specialist diabetes care within the Pirkanmaa Wellbeing Services County (Pirha)
Lab values
- Not using a continuous glucose monitoring system
- 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
Age
- Age \< 18 years
Other
- Pregnancy
- Does not accept remote care
- Presence of retinopathy
- No retinal imaging performed within the past 12 months
- Scheduled hospital outpatient visits for other specialties within the next 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.