To study the impact of age-patient-related, treatment-related, behavior and structure of care-related variables on glycemic control and quality of life in children, adolescents and young adults with type-1 diabetes mellitus

Glycemic control and quality of life in children, adolescents and young adults with type-1 diabetes mellitus described in a world-wide cross-sectional study in 2012: Impact of age-patient-related, treatment-related, behavior and structure of care-related variables. - TEENs

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/08/002925

Enrollment

5000

Registered

2012-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 1 Diabetes Mellitus Health Condition 2: E109- Type 1 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged > 8 to the study entry with type-1 diabetes mellitus. 2. Signed written informed consent obtained from the patient if applicable or from the parent(s)/guardian.

Exclusion criteria

Exclusion criteria: 1. T1DM diagnosed after 18 years of age for patients 18 years old. 2. Diabetes other than type-1 diabetes (e.g. type-2 diabetes, secondary diabetes mellitus (pancreatic history, drug- or chemical-induced diabetes), genetic defects in Î²-cell function or insulin action). 3. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 7 consecutive days or more within the last 3 months. 4. Patients with known uncontrolled or inadequately controlled hyperthyroidism or hypothyroidism. 5. Change from pump regimen to multiple insulin injections regimen within the last 3 months. 6. Change from multiple insulin injections regimen to pump regimen within the last 3 months. 7. Treatment with oral antidiabetic drugs (OAD) (except metformin which is permitted) at any time from the diagnosis. 8. Treatment with any investigational drug within the last 3 months. 9. Any known medical condition impacting red blood cells production or destruction such as hemoglobinopathy, polycythemia, splenectomy, iron deficiency anemia, hemorrhage, myelodysplastic disease or receipt or donation of blood or plasma products within the last 3 months. 10. Patient or parent/legally authorized representative(s) unable to understand the nature and scope of the study, unable to read and write or unlikely to comply with the protocol, e.g. inability and unwillingness to complete the questionnaires. 11. Children or relatives of the Investigators, research assistants, study coordinator or other staff directly involved in the conduct of the protocol, employee of the Sponsor or of Sponsorâ??s representatives.

Design outcomes

Primary

Measure	Time frame
Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups.Timepoint: Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups.	—

Secondary

Measure	Time frame
Quality of life (QOL) of T1DM patients evaluated with PedsQL questionnaires for patients and parents/guardian in the different predefined age classes (subgroup analysis with controlled and uncontrolled patientsTimepoint: at the time of visit	—

Countries

Algeria, Argentina, Denmark, Egypt, France, Germany, Hungary, India, Italy, Jordan, Lebanon, Mexico, Morocco, Portugal, Romania, Russian Federation, Slovenia, South Africa, Spain, Sweden, United States of America

Contacts

Public ContactMs Gayatri Jaiswal

Sanofi Synthelabo (I) Ltd

Gayatri.Jaiswal@sanofi.com912230707806

Outcome results