Need-driven Treatment of the Patients With Type 1 Diabetes

NCT07128992 | Not Yet Recruiting

• 2 other identifiers: R25006LT67674
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Type 1 Diabetes (T1D); Glucose Control

Keywords

type 1 diabetes; complication; glycemic control

Outcome Measures

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

  At the baseline and at 24 months of follow-up

Study Arms (1)

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%).

Other: Control visit interval

Interventions

Control visit interval OTHER

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.

Adults (≥18 years) with type1 diabetes under the care of the Pirkanmaa Wellbeing Service

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tampere University Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Saara Metso, MD, PhD

  Tampere University Hospital, Pirkanmaa Wellbeing County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saara E Metso, MD, PhD

CONTACT

+358405310154; saara.metso@pirha.fi

Päivi Hannula, MD, PhD

CONTACT

+358331164402; paivi.hannula@pirha.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the unit of endocrinology, Associate professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 19, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08