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Looking for Early Long-Term Diabetes Complications in Young People With Type 1 Diabetes

Studies early warning signs of diabetes complications in children with type 1 diabetes.

Plain-language title generated from the registry record
Registry title: Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes

Key facts

Where
Herlev, DenmarkSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 18 years old?

Source: NCT05159856, who can take part

Where in Denmark

  • Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Steno Diabetes Center Copenhagen
Trial code
NCT05159856
Record updated
3 June 2025
Original description
Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).Read full original descriptionShow less

Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes

Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).

Background: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed.

Methods: A prospectivel study of 400 children, aged 6-18 years old, with T1D>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected.

Blood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades.

Perspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.

Inclusion: T1D>12 months; 6-18 years old prior to inclusion; Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen; Speaks and reads Danish well enough to understanding the given oral and written information; There is a written consent from the guardianship holder/holders for the child.

Exclusion: Known cardiovascular disease; T1D < 12 months; Antihypertensive treatment.

ClinicalTrials.gov NCT05159856