Type1diabetesDIATAGNCT04007809
Phenotypic and Genotypic Characterization of New-onset Type I Diabetes
A study testing Glucagon in people with Type1diabetes, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes de novo according to American Diabetes Association criteria:
- Polyuria, polydipsia, weight loss ± ketoacidosis
- Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at the 120th minute of an Oral Glucose Tolerance Test (OGTT) AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg/dL.
- Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
- Age between 6 months and 18 years.
- Male or female.
- Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1).
- Free written and oral consent.
Who cannot join
- Children under 6 months of age.
- Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion.
- Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion.
- Obesity defined by a Body Mass Index (BMI) with a z-score >+3 Standard Deviation.
- Hepatic, renal or adrenal insufficiency.
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- History of spinal cord allograft.
- History of post-hemolytic-uremic diabetes.
- Absence of anti-pancreatic islet auto-antibodies.
- Dysmorphic with suspicion of underlying genetic syndrome.
- Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
Read the detailed description
Type 1 diabetes (T1D) is a common chronic disease in childhood. Clinical presentation at onset of T1D can vary among patients from long-standing diabetes triad symptoms (polyuria, polydipsia and weight loss) to coma and ketoacidosis. The initial clinical presentation of T1D was shown to have long-term influence on glycemic control of the patient. The investigators initiated a collaborative consortium including six pediatric clinics in Belgium to better characterize new-onset T1D patients.
Hypothesis :
- Different subgroups of T1D patients might exist, underlying different physiopathology of T1D :
- The investigators will first investigate the presence of biomarkers in different fluids (e.g. urine, blood, feces,...).
- The investigators will correlate results with clinical parameters of glycemic control. Dynamic tests (HOMA and stimulated C peptide) will be realized at 2 defined time points of the follow-up.
- Glucose variability can be influenced by external factors (e.g. diet, physical activity, Quality of Life (QoL),...) The investigators will evaluate those external factors using approved questionnaires. They will presented to the patient and its parents at 2 defined time points.
- Conditions
- Type1diabetes
- Being tested
- Glucagon
- Keywords
- type 1 diabetes, children, biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonOther
Also called Glucagen
Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
| Study group | Role | What they receive |
|---|---|---|
| New-onset Type 1 diabetes | Experimental | Not described Receives: Other: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms
weight in kilograms
Measured: up to 18 months after diagnosis
Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter
Height in centimeter
Measured: up to 18 months after diagnosis
Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²)
Body mass index (kg/m²)
Measured: up to 18 months after diagnosis
Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%)
glycemic variability (%)
Measured: up to 18 months after diagnosis
Follow-up of laboratory results - glycemia (mg/dL)
glycemia (mg/dL)
Measured: up to 18 months after diagnosis
Follow-up of laboratory results - Insulin (mUI/L)
Insulin (mUI/L)
Measured: up to 18 months after diagnosis
Follow-up of laboratory results - HbA1C (%)
HbA1C (%)
Measured: up to 18 months after diagnosis
Follow-up of laboratory results - C-peptide (mUI/L)
C-peptide (mUI/L)
Measured: up to 18 months after diagnosis
Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires.
Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC)
Measured: up to 18 months after diagnosis
Evaluation and follow-up of physical activity
Physical Activity Questionnaire (PAQ). This questionnaire consists of 8 items. Once you have a value from 1 to 5 for each of the 8 items (items 1 to 8) used in the Physical Activity composite score, you simply take the mean of these 8 items, which results in the final PAQ activity summary score.
A score of 1 indicates low physical activity, wheareas a score of 5 indicates high physical activity.
Measured: up to 18 months after diagnosis
Evaluation and follow-up of quality of life: DisabKids Questionnaires
DisabKids Questionnaires. The paper version of DISABKIDS consisted of the generic health related quality of life questionnaire for 8- to 18-year-olds (37 items) and the DISABKIDS Diabetes module (10 items). The questionnaire is designed to measure health related quality of life of children with a chronic medical condition. Questions are answered on a Likert type scale of 1-5 points. Lower scores correspond to better quality of life.
Measured: up to 18 months after diagnosis
Secondary outcomes (1)
Production of prediction model of β-cell mass evolution
Composite score using clinical parameters and laboratory results
Measured: up to 18 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Jun 2019
- Primary completion15 Aug 2022 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, BESPEED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007809
- Sponsor's protocol ID
- DIATAG
- Acronym
- DIATAG
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2019
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polle OG, Delfosse A, Martin M, Louis J, Gies I, den Brinker M, Seret N, Lebrethon MC, Mouraux T, Gatto L, Lysy PA; DIATAG Working Group. Glycemic Variability Patterns Strongly Correlate With Partial Remission Status in Children With Newly Diagnosed Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2360-2368. doi: 10.2337/dc21-2543.
PubMed 35994729
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04007809
- Acronym / sponsor ID
- DIATAG / DIATAG
- Conditions
- Type1diabetes
- Keywords
- type 1 diabetes, children, biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, BESPEED
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
Detailed description
Type 1 diabetes (T1D) is a common chronic disease in childhood. Clinical presentation at onset of T1D can vary among patients from long-standing diabetes triad symptoms (polyuria, polydipsia and weight loss) to coma and ketoacidosis. The initial clinical presentation of T1D was shown to have long-term influence on glycemic control of the patient. The investigators initiated a collaborative consortium including six pediatric clinics in Belgium to better characterize new-onset T1D patients.
Hypothesis :
- Different subgroups of T1D patients might exist, underlying different physiopathology of T1D :
- The investigators will first investigate the presence of biomarkers in different fluids (e.g. urine, blood, feces,...).
- The investigators will correlate results with clinical parameters of glycemic control. Dynamic tests (HOMA and stimulated C peptide) will be realized at 2 defined time points of the follow-up.
- Glucose variability can be influenced by external factors (e.g. diet, physical activity, Quality of Life (QoL),...) The investigators will evaluate those external factors using approved questionnaires. They will presented to the patient and its parents at 2 defined time points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New-onset Type 1 diabetes | Experimental | Other: Glucagon |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Type 1 diabetes de novo according to American Diabetes Association criteria:
- Age between 6 months and 18 years.
- Male or female.
- Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1).
- Free written and oral consent.
Key exclusion criteria (11 listed)
- Children under 6 months of age.
- Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion.
- Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion.
- Obesity defined by a Body Mass Index (BMI) with a z-score >+3 Standard Deviation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucagonAlso: GlucagenEvery patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg). | Other | New-onset Type 1 diabetes |
Primary outcome
Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms
Time frame: up to 18 months after diagnosis
weight in kilograms
Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter
Time frame: up to 18 months after diagnosis
Height in centimeter
Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²)
Time frame: up to 18 months after diagnosis
Body mass index (kg/m²)
Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%)
Time frame: up to 18 months after diagnosis
glycemic variability (%)
Follow-up of laboratory results - glycemia (mg/dL)
Time frame: up to 18 months after diagnosis
glycemia (mg/dL)
Follow-up of laboratory results - Insulin (mUI/L)
Time frame: up to 18 months after diagnosis
Insulin (mUI/L)
Follow-up of laboratory results - HbA1C (%)
Time frame: up to 18 months after diagnosis
HbA1C (%)
Follow-up of laboratory results - C-peptide (mUI/L)
Time frame: up to 18 months after diagnosis
C-peptide (mUI/L)
Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires.
Time frame: up to 18 months after diagnosis
Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC)
Evaluation and follow-up of physical activity
Time frame: up to 18 months after diagnosis
Physical Activity Questionnaire (PAQ). This questionnaire consists of 8 items. Once you have a value from 1 to 5 for each of the 8 items (items 1 to 8) used in the Physical Activity composite score, you simply take the mean of these 8 items, which results in the final PAQ activity summary score. A score of 1 indicates low physical activity, wheareas a score of 5 indicates high physical activity.
Evaluation and follow-up of quality of life: DisabKids Questionnaires
Time frame: up to 18 months after diagnosis
DisabKids Questionnaires. The paper version of DISABKIDS consisted of the generic health related quality of life questionnaire for 8- to 18-year-olds (37 items) and the DISABKIDS Diabetes module (10 items). The questionnaire is designed to measure health related quality of life of children with a chronic medical condition. Questions are answered on a Likert type scale of 1-5 points. Lower scores correspond to better quality of life.
1 secondary outcome
Production of prediction model of β-cell mass evolution
Time frame: up to 18 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 35994729Polle OG, Delfosse A, Martin M, Louis J, Gies I, den Brinker M, Seret N, Lebrethon MC, Mouraux T, Gatto L, Lysy PA; DIATAG Working Group. Glycemic Variability Patterns Strongly Correlate With Partial Remission Status in Children With Newly Diagnosed Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2360-2368. doi: 10.2337/dc21-2543.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon in people with Type1diabetes, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms (time frame: up to 18 months after diagnosis). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.