Diabetes Mellitus Type 1LifeOneNCT07289204
FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes
An observational study of Diabetes Mellitus Type 1 and Healthy Ageing, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 1, Healthy Ageing
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- 29 Jan 2024to 31 Dec 2030
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants of the Finnish Diabetic Nephropathy (FinnDiane) Study living in the Helsinki capital area. Controls will be recruited from spouses to match for sex and socioeconomic factors.
Who may be able to join
- Participants of the Finnish Diabetic Nephropathy Study
- Type 1 diabetes
- With age above 65 years
- Informed consent provided
Who cannot join
- Age below 65 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus Type 1, Healthy Ageing
- Keywords
- Aging, Healthy Aging, Diabetes Mellitus, Type 1, Prospective Studies, Cohort Studies, Geriatric Assessment, Finland
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Participants of the Finnish Diabetic Nephropathy Study, age above 65 years. | |
| Controls | Age above 65 years, no diabetes with insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy ageing in people with type 1 diabetes mellitus
Key Characteristics and Clinical Implications of healthy aging in individuals with type 1 diabetes mellitus
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Secondary outcomes (5)
Physical capacity
The locomotor domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Cognitive function
The cognitive domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Psychological well-being
The psychological domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Vitality
The vitality domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Sensory function
The sensory domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
Measured: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start29 Jan 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Folkhälsan Research Center
- Responsible party
- Principal investigator, Lena M. Thorn, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289204
- Sponsor's protocol ID
- HUS/4387/2023
- Acronym
- LifeOne
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level data for the study participants are not publicly available because of the restrictions due to the study consent provided by the participant at the time of data collection. Researchers may propose collaboration to research the individual level data with correspondence with the lead investigator.
Publications
Nicklen J, Satuli-Autere S, Rimpelainen K, Dufva A, Ylinen A, Franzen EM, Eriksson MI, Jansson Sigfrids F, Ohman H, Thorn LM. FinnDiane LifeOne Study: influence of ageing on people with type 1 diabetes - a prospective observational cohort study protocol. BMJ Open. 2026 Sep 11;16(9):e122380. doi: 10.1136/bmjopen-2026-122380.
PubMed 42731824
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07289204
- Acronym / sponsor ID
- LifeOne / HUS/4387/2023
- Conditions
- Diabetes Mellitus Type 1, Healthy Ageing
- Keywords
- Aging, Healthy Aging, Diabetes Mellitus, Type 1, Prospective Studies, Cohort Studies, Geriatric Assessment, Finland
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Folkhälsan Research Center
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Dec 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | –Participants of the Finnish Diabetic Nephropathy Study, age above 65 years. |
| Controls | – | –Age above 65 years, no diabetes with insulin therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants of the Finnish Diabetic Nephropathy (FinnDiane) Study living in the Helsinki capital area. Controls will be recruited from spouses to match for sex and socioeconomic factors.
Key inclusion criteria (4 listed)
- Participants of the Finnish Diabetic Nephropathy Study
- Type 1 diabetes
- With age above 65 years
- Informed consent provided
Key exclusion criteria (1 listed)
- Age below 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Physical capacity
Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Cognitive function
Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Psychological well-being
Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Vitality
Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
Sensory function
Time frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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 24 Dec 2025.
- Derived from this study: PubMed 42731824Nicklen J, Satuli-Autere S, Rimpelainen K, Dufva A, Ylinen A, Franzen EM, Eriksson MI, Jansson Sigfrids F, Ohman H, Thorn LM. FinnDiane LifeOne Study: influence of ageing on people with type 1 diabetes - a prospective observational cohort study protocol. BMJ Open. 2026 Sep 11;16(9):e122380. doi: 10.1136/bmjopen-2026-122380.
- Individual participant dataSharing planned: No. Individual-level data for the study participants are not publicly available because of the restrictions due to the study consent provided by the participant at the time of data collection. Researchers may propose collaboration to research the individual level data with correspondence with the lead investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 1 and Healthy Ageing, run by Helsinki University Central Hospital at 1 site in Finland.
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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07289204, which also lists 1 linked publication.
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 24 Dec 2025.