Type 1 Diabetes (T1D)NCT07128992
Need-driven Treatment of the Patients With Type 1 Diabetes
An observational study of Type 1 Diabetes (T1D) and Glucose Control, run by Tampere University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D), Glucose Control
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2025to 31 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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).
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Type 1 Diabetes (T1D), Glucose Control
- Being tested
- Control visit interval
- Keywords
- type 1 diabetes, complication, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control visit intervalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults (≥18 years) with type1 diabetes under the care of the Pirkanmaa Wellbeing Service | Eligible participants are patients with type 1 diabetes who use continuous glucose monitoring systems, have no complications or other conditions requiring frequent hospital or outpatient care, and are in good glycemic control (HbA1c < 53 mmol/mol, TIR > 70%, TBR < 4%, TAR > 25%). Receives: Other: Control visit interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in good glycemic control
Percentage of patients with TIR > 70%, GMI < 53 mmol/mol, and HbA1c < 53 mmol/mol
Measured: At the baseline and at 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start6 Oct 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saara Metso, Tampere University Hospital
- Investigators
- Saara Metso, MD, PhD, Principal investigator, Tampere University Hospital, Pirkanmaa Wellbeing County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128992
- Sponsor's protocol ID
- R25006L
- Other IDs
- T67674
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07128992
- Acronym / sponsor ID
- R25006L
- Conditions
- Type 1 Diabetes (T1D), Glucose Control
- Keywords
- type 1 diabetes, complication, glycemic control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults (≥18 years) with type1 diabetes under the care of the Pirkanmaa Wellbeing Service | – | Other: Control visit intervalEligible participants are patients with type 1 diabetes who use continuous glucose monitoring systems, have no complications or other conditions requiring frequent hospital or outpatient care, and are in good glycemic control (HbA1c < 53 mmol/mol, TIR > 70%, TBR < 4%, TAR > 25%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control visit intervalStudy 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. | Other | Adults (≥18 years) with type1 diabetes under the care of the Pirkanmaa Wellbeing Service |
Primary outcome
Percentage of patients in good glycemic control
Time frame: At the baseline and at 24 months of follow-up
Percentage of patients with TIR > 70%, GMI < 53 mmol/mol, and HbA1c < 53 mmol/mol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saara Metso, MD, PhD principal investigator
Tampere University Hospital, Pirkanmaa Wellbeing County
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Glucose Control, run by Tampere University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saara E Metso, MD, PhD (+358405310154, saara.metso@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients in good glycemic control (time frame: At the baseline and at 24 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.