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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Late Onset | Participants diagnosed with Type 1 diabetes at over 30 years of age. | ||
| 18 to 30 | Participants diagnosed with Type 1 diabetes between 18 and 30 years of age |
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| Measure | Description | Time Frame |
|---|---|---|
| C-peptide value at a year | 12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide. | 12 months |
| Change in C-peptide over a year | Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide value at 12 months | Mean C-peptide at 12 months assessed using MMTT and home blood samples | 12 months |
| Glucose variability & hypoglycemia | Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM) |
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Inclusion Criteria:
Exclusion criteria
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Recent clinical diagnosis of type 1 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Angus Jones, MBBS MRCP | NIHR Exeter Clinical Research Facility | Study Director |
| Nicholas Thomas, MRCP | NIHR Exeter Clinical Research Facility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon & Exeter NHS Foundation Trust | Exeter | Devon | EX2 5DW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30969375 | Background | Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Serum, Plasma, DNA,
| 12 months |
| Change in dried blood spot C-peptide | Rate of change in home dried blood spot C-peptide over 12 months | 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |