Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682457
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Mellitus, Type 1 Progression

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 196 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Serum, Plasma, DNA,

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recent clinical diagnosis of type 1 diabetes
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anita Hill 01392408184 Anita.Hill2@nhs.net
Contact: Peter Tippett 01392408184 rde-tr.DiabetesResearch@nhs.net

Locations
Layout table for location information
United Kingdom
Royal Devon & Exeter NHS Foundation Trust Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Contact: Nicholas Thomas, MRCP       n.thomas3@exeter.ac.uk   
Contact: Anita Hill    +44 (0) 1392 408184    Anita.Hill2@nhs.net   
Principal Investigator: Angus G Jones, MRCP         
Sub-Investigator: Nicholas Thomas, MRCP         
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
Layout table for investigator information
Study Director: Angus Jones, MBBS MRCP NIHR Exeter Clinical Research Facility
Principal Investigator: Nicholas Thomas, MRCP NIHR Exeter Clinical Research Facility
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04682457    
Other Study ID Numbers: 2003962
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases