Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age. (DROPLeT)
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|ClinicalTrials.gov Identifier: NCT04682457|
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : March 11, 2022
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|
|Diabetes Mellitus, Type 1 Progression|
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 Type :||Observational|
|Estimated Enrollment :||196 participants|
|Official Title:||Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2023|
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
- C-peptide value at a year [ Time Frame: 12 months ]12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.
- Change in C-peptide over a year [ Time Frame: 12 months ]Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits
- C-peptide value at 12 months [ Time Frame: 12 months ]Mean C-peptide at 12 months assessed using MMTT and home blood samples
- Glucose variability & hypoglycemia [ Time Frame: 12 months ]Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM)
- Change in dried blood spot C-peptide [ Time Frame: 12 months ]Rate of change in home dried blood spot C-peptide over 12 months
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682457
|Contact: Anita Hill||01392408184||Anita.Hill2@nhs.net|
|Contact: Peter Tippett||01392408184||rde-tr.DiabetesResearch@nhs.net|
|Royal Devon & Exeter NHS Foundation Trust||Recruiting|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Contact: Nicholas Thomas, MRCP firstname.lastname@example.org|
|Contact: Anita Hill +44 (0) 1392 408184 Anita.Hill2@nhs.net|
|Principal Investigator: Angus G Jones, MRCP|
|Sub-Investigator: Nicholas Thomas, MRCP|
|Study Director:||Angus Jones, MBBS MRCP||NIHR Exeter Clinical Research Facility|
|Principal Investigator:||Nicholas Thomas, MRCP||NIHR Exeter Clinical Research Facility|