First-degree relatives of people with acute-onset type 1 diabetes.
Conditions
Interventions
None listed
Sponsors
Sanofi K. K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Having a first-degree relative diagnosed with acute-onset type 1 diabetes* or SPIDDM**, or a first-degree relative with type 1 diabetes who currently have completely depleted endogenous insulin secretion (the onset history is unknown)*** (proband) * The proband is considered to have acute-onset type 1 diabetes when he or she meets the following criteria 1 and 2. However, if islet autoantibody status are unknown, he or she is considered to have acute-onset type 1 diabetes when he or she meets the following criteria 1 and 3. ** The proband is considered to have SPIDDM when he or she meets the following criteria 2 to 4. *** The proband is considered to have type 1 diabetes and currently have completely depleted endogenous insulin secretion (the onset history is unknown) when he or she meets the following criterion 5. 1. The condition at the time of onset meets any of the following -Required continuous insulin treatment within 3 months after the diagnosis of diabetes -Observed ketosis or ketoacidosis within about 3 months after the appearance of diabetes symptoms 2. He or she tested positive for any of islet autoantibodies at least once. 3. By the time of the participants enrollment, a deficiency of endogenous insulin secretion (fasting serum C-peptide under 0.6 ng/ml) was observed. 4. At the time of type 1 diabetes diagnosis, ketosis or ketoacidosis was not observed, and insulin therapy was required more than 3 months after the diagnosis of diabetes. 5. Although the onset history of type 1 diabetes is unknown, complete depletion of endogenous insulin secretion (fasting serum C-peptide below the limit of detection) was observed. 2)Being younger than 50 years old at the time of enrollment 3)Being able to give voluntary written consent (If the participant is under 18 years of age, an informed consent will be obtained from a legal representative.)
Exclusion criteria
Exclusion criteria: 1)Individuals with previously diagnosed or developed type 1 or type 2 diabetes. 2)His or her proband meets any of the following criteria 1. Has been diagnosed with SPIDDM (probable), fulminant type 1 diabetes, or type 2 diabetes. 2. Has a past or current history of cancer or hepatitis. 3. The course of the type 1 diabetes at the time of diagnosis and onset is unclear.* * This criterion does not apply to probands with type 1 diabetes who currently have completely depleted endogenous insulin secretion (the onset history is unknown). 4. Neither the presence of islet autoantibodies at the time of diagnosis nor residual endogenous insulin secretion capacity is known.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of individuals who are positive for islet autoantibodies and have or do not have glucose metabolism disorders among first-degree relatives of people with acute-onset type 1 diabetes or slowly progressive insulin-dependent diabetes mellitus (SPIDDM) (definite), or with type 1 diabetes who currently have completely depleted endogenous insulin secretion (the onset history is unknown). | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the correlation between the staging of type 1 diabetes and the presence or absence of susceptible/resistant human leukocyte antigen (HLA) genes in participants positive for islet autoantibodies. | — |
Countries
Japan
Contacts
Public ContactTakashi Takahashi
IQVIA Services Japan Real World Evidence Services
Outcome results
None listed