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

Phase 4

Completed

• Conditions: Health Condition 1: null- Type 1 Diabetes MellitusHealth Condition 2: E109- Type 1 diabetes mellitus without complications

• Registration Number: CTRI/2012/08/002925
• Lead Sponsor: Sanofi Synthelabo India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5000

Inclusion Criteria

1. Patients aged > 8 to < 25 years old, diagnosed at least 1 year prior 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

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 β-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.

Study & Design

• Study Type: Observational
• Study Design: Not specified