DROPLeT: Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The study aims to evaluate progression of type 1 diabetes. Primary analysis will be conducted on those with >=1 diabetes autoantibody positive (GAD, IA2 ZNT8). Sensitivity analysis will be performed by repeating all analysis defining T1D as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for T1D (T1DGRS>5th centile of a control population).
Further aims will be to evaluate the utility of dried blood spot testing to detect change in C-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Late Onset Participants diagnosed with Type 1 diabetes at over 30 years of age. |
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| 18 to 30 Participants diagnosed with Type 1 diabetes between 18 and 30 years of age |
Outcome Measures
Primary Outcome Measures
- C-peptide value at a year [12 months]
12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.
- Change in C-peptide over a year [12 months]
Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits
Secondary Outcome Measures
- C-peptide value at 12 months [12 months]
Mean C-peptide at 12 months assessed using MMTT and home blood samples
- Glucose variability & hypoglycemia [12 months]
Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM)
- Change in dried blood spot C-peptide [12 months]
Rate of change in home dried blood spot C-peptide over 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
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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.
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Insulin treated at the time of recruitment
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Able and willing to provide informed consent.
Exclusion criteria
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Pregnancy
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Known monogenic diabetes
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Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Devon & Exeter NHS Foundation Trust | Exeter | Devon | United Kingdom | EX2 5DW |
Sponsors and Collaborators
- Royal Devon and Exeter NHS Foundation Trust
Investigators
- Study Director: Angus Jones, MBBS MRCP, NIHR Exeter Clinical Research Facility
- Principal Investigator: Nicholas Thomas, MRCP, NIHR Exeter Clinical Research Facility
Study Documents (Full-Text)
None provided.More Information
Publications
- 2003962