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NCT Number: NCT07289204

FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes

Healthy aging refers to functional ability that enables well-being in older individuals. The focus thus shifts from chronological age to functional capacity and the individual's own experience of well-being. Type 1 diabetes is a chronic condition characterized by elevated blood glucose levels, which increases the risk of cardiovascular diseases and premature death. However, the life expectancy of individuals with type 1 diabetes has significantly improved due to advances in diabetes care.

There is limited research on aging with type 1 diabetes, and this study is at the forefront of addressing this gap by examining aging-and especially healthy aging-in type 1 diabetes from multiple perspectives. The goals are to investigate how individuals with type 1 diabetes age and what their functional capacity is compared to individuals without insulin-treated diabetes. The other aim is to identify factors in midlife that predict healthy aging in people with type 1 diabetes.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HUS Helsinki University Hospital

Helsinki, Finland

About this study

Ageing with type 1 diabetes is an emerging challenge due to improved life-expectancy of people with type 1 diabetes. While those who survive to an older age are considered survivors, the many years with type 1 diabetes and the chronic dysglycaemia inevitably also has negative health impacts on people living with this chronic disease. With scarce research in this area, ageing in type 1 diabetes has been identified as a research gap.

With this study, the aim is to assess the impact of ageing in people with type 1 diabetes via thorough characterization of older adults with type 1 diabetes, in comparison to matched controls. This will be accomplished through a comprehensive assessment of the participants' metabolic profile, body composition, vascular health, autonomic function, and a geriatric assessment focusing on the functional ability of the participants. In addition, this study will assess what type of challenges older adults with type 1 diabetes face regarding self-management, diabetes care, and daily life.

This study is a sub-study of the national Finnish Diabetic Nephropathy Study, initiated in 1997 and including adults with type 1 diabetes. Individuals over 65 living in the Helsinki capital area will now be invited for a regular FinnDiane study visit, as well as an additional visit for a geriatric assessment. The aim is to study 300 FinnDiane study participants and recruit a minimum of 100 matched controls. This cohort will be prospectively followed with a revisit after three to five years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of the Finnish Diabetic Nephropathy Study
  • Type 1 diabetes
  • With age above 65 years
  • Informed consent provided

Exclusion criteria

  • Age below 65 years

Treatment and study plan

Primary outcomes

  1. Healthy ageing in people with type 1 diabetes mellitus

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    Key Characteristics and Clinical Implications of healthy aging in individuals with type 1 diabetes mellitus

Secondary outcomes

  1. Physical capacity

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    The locomotor domain of the individual's intrinsic capacity, based on the framework for healthy ageing.

  2. Cognitive function

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    The cognitive domain of the individual's intrinsic capacity, based on the framework for healthy ageing.

  3. Psychological well-being

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    The psychological domain of the individual's intrinsic capacity, based on the framework for healthy ageing.

  4. Vitality

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    The vitality domain of the individual's intrinsic capacity, based on the framework for healthy ageing.

  5. Sensory function

    Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

    The sensory domain of the individual's intrinsic capacity, based on the framework for healthy ageing.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Folkhälsan Research Center
  • University of Helsinki

Registry information

Acronym: LifeOne

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Dec 17, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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