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NCT Number: NCT04682457

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Disease Attributes Disease Progression Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Progression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Devon & Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. C-peptide value at a year

    Time frame: 12 months

    12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.

  2. 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

Secondary outcomes

  1. C-peptide value at 12 months

    Time frame: 12 months

    Mean C-peptide at 12 months assessed using MMTT and home blood samples

  2. Glucose variability & hypoglycemia

    Time frame: 12 months

    Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM)

  3. Change in dried blood spot C-peptide

    Time frame: 12 months

    Rate of change in home dried blood spot C-peptide over 12 months

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Registry information

Acronym: DROPLeT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2020
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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