NCT04682457Completed
Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.
Source: ClinicalTrials.gov · Last updated 4 Jun 2024
Brief summary (registry, in English)
The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year. This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 130 (actual)
- First submitted
- 15 Dec 2020
- Start date
- 1 Nov 2019
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Diseases
- Type 1 diabetes
- NCT number
- NCT04682457
What you commit to
- Study type: Observational
- Participants enrolled: 130
- From 1 Nov 2019 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known monogenic diabetes
- Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
Other
- Pregnancy
Who the study is looking for
- Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
- Aged \>30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
- Insulin treated at the time of recruitment
- Able and willing to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Devon & Exeter NHS Foundation Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.