Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial has several different groups (called "work packages" or WPs). The criteria differ depending on which group a person may be considered for.

Group 1 (WP1) – Newly diagnosed type 1 diabetes, ages 2–30:

• People newly diagnosed with type 1 diabetes according to established international criteria, with symptoms such as excessive thirst, frequent urination, and weight loss, and blood sugar or HbA1c results above certain thresholds.
• People who have one or more specific immune markers in their blood (called anti-islet autoantibodies) that are associated with type 1 diabetes.
• People aged between 2 and 30 years.
• People weighing at least 17 kg (needed for blood sample collection).
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Group 2 (WP2) – Newly diagnosed type 1 diabetes, ages 2–18:

• People newly diagnosed with type 1 diabetes according to established international criteria, with symptoms such as excessive thirst, frequent urination, and weight loss, and blood sugar or HbA1c results above certain thresholds.
• People who have one or more specific immune markers in their blood (anti-islet autoantibodies) associated with type 1 diabetes.
• People aged between 2 and 18 years (under 18).
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Group 3 (WP3) – Healthy adult relatives of people with diabetes:

• Adults over 18 years of age.
• People who have no blood markers of diabetes (no autoantibodies, normal HbA1c, normal blood sugar, and normal insulin-producing cell function).
• People who are a close (first-degree) family member — such as a parent, sibling, or child — of someone already being treated for diabetes meeting established criteria.
• Both male and female people are included.
• People who have given free, written, and verbal agreement to participate.

Group 4 (WP4) – Children with cystic fibrosis or pancreas surgery, ages 2–18:

• Children aged 2 to 18 years diagnosed with cystic fibrosis where the pancreas's hormone-producing function is affected, and who experience regular episodes of high or low blood sugar.
• Children aged 2 to 18 years who have had all or part of their pancreas surgically removed and who experience regular episodes of high or low blood sugar.
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Group 5 (WP5) – Children aged 2–18 who have had an insulin test:

• Children aged 2 to 18 years who have undergone a medical test involving insulin to investigate possible problems with growth hormone, the adrenal glands, or the pituitary gland.
• People weighing at least 17 kg.
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Group 6 (WP6) – Type 1 diabetes (including established cases), ages 2–18:

• People with type 1 diabetes according to established international criteria, with symptoms such as excessive thirst, frequent urination, and weight loss, and blood sugar or HbA1c results above certain thresholds.
• People who have one or more specific immune markers in their blood (anti-islet autoantibodies) associated with type 1 diabetes.
• People aged between 2 and 18 years (under 18).
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Group 7 (WP7) – Newly diagnosed type 1 diabetes, ages 2–18:

• People newly diagnosed with type 1 diabetes according to established international criteria, with symptoms such as excessive thirst, frequent urination, and weight loss, and blood sugar or HbA1c results above certain thresholds.
• People who have one or more specific immune markers in their blood (anti-islet autoantibodies) associated with type 1 diabetes.
• People aged between 2 and 18 years.
• People weighing at least 17 kg.
• Both male and female people are included.
• People (or their guardians) who have given free, written, and verbal agreement to participate.

Who may not be able to join:

The following exclusion criteria apply across the various groups (some criteria apply only to certain groups — the trial site can clarify which apply):

• Children under 2 years of age.
• People weighing less than 17 kg (applies to groups where blood samples are required — confirm with trial site which groups this applies to).
• People currently taking certain medications known to affect how the body produces or responds to insulin, such as sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanides, or incretins.
• People who have been newly diagnosed with coeliac disease (confirmed by a bowel tissue sample) within the past month at the time of joining.
• People who have another autoimmune or autoinflammatory condition (other than type 1 diabetes), or an active cancer, at the time of joining.
• People with severe obesity, defined by a specific body mass index measurement (a BMI z-score above +3 SD — the trial site can explain what this means for a specific person).
• People with liver, kidney, or adrenal gland failure (does not apply to WP5).
• People who have previously had a bone marrow transplant.
• People whose diabetes developed following a condition called haemolytic-uraemic syndrome (a serious illness affecting the blood and kidneys).
• People with epilepsy (applies to WP1, WP6, WP7, and WP3 — confirm with trial site).
• People who do not have the specific immune blood markers (anti-islet autoantibodies) required for the diabetes groups (WP1, WP2, WP7).
• People with physical features that suggest an underlying genetic condition.
• People who have taken part in another study in the past 3 months where they received blood products or treatments that could affect the immune system.
• People who are pregnant (applies to WP3 — confirm with trial site for other groups).
• Adults with a history of reduced blood flow to the heart muscle (ischaemic cardiomyopathy) (applies to WP3).

Important: Always verify eligibility with the trial site directly before applying.