Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

Diabetes Mellitus, Type 1 Clinical Trial

— DROPLeT  

Official title:

Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04682457
• Other study ID #: 2003962
• Status: Active, not recruiting
• Start date: November 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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. Exclusion criteria
• Pregnancy
• Known monogenic diabetes
• Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Progression

Locations

Country	Name	City	State
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide value at a year	12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.	12 months
Primary	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
Secondary	C-peptide value at 12 months	Mean C-peptide at 12 months assessed using MMTT and home blood samples	12 months
Secondary	Glucose variability & hypoglycemia	Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM)	12 months
Secondary	Change in dried blood spot C-peptide	Rate of change in home dried blood spot C-peptide over 12 months	12 months