Need-driven Treatment of the Patients With Type 1 Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosis of type 1 diabetes

Treatment with multiple daily injections or insulin pump therapy

Duration of diabetes ≥ 1 year

Disqualifiers

Age < 18 years

Duration of diabetes < 1 year

Pregnancy

Not using multiple daily injections or insulin pump therapy

Trial population

The study population includes adults (≥18 years) with type 1 diabetes in good glucose control and under the care of the Pirkanmaa Wellbeing Services County (Pirha).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Control visit interval

    Other intervention

    Study investigates whether it is safe to extend the interval of routine calendar-based follow-up visits from every 12 to every 24 months in patients with type 1 diabetes.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: Adults (≥18 years) with type1 diabetes under the care of the Pirkanmaa Wellbeing Service1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients in good glycemic control

Percentage of patients with TIR \> 70%, GMI \< 53 mmol/mol, and HbA1c \< 53 mmol/mol

Time frame
At the baseline and at 24 months of follow-up

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: