CTRI/2012/08/002925 [Registered on: 28/08/2012] Trial Registered Retrospectively
Last Modified On:
13/11/2018
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Other
Public Title of Study
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
Scientific Title of Study
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.
Trial Acronym
TEENs
Secondary IDs if Any
Secondary ID
Identifier
DIREG_C_05444 dated 21 March 2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Ms Gayatri Jaiswal
Designation
Senior Clinical Project Leader
Affiliation
Sanofi Synthelabo (I) Ltd
Address
Sanofi
A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai
Mumbai MAHARASHTRA 400093 India
Phone
912230707806
Fax
Email
Gayatri.Jaiswal@sanofi.com
Details of Contact Person Public Query
Name
Ms Gayatri Jaiswal
Designation
Senior Clinical Project Leader
Affiliation
Address
Sanofi
A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai
MAHARASHTRA 400093 India
Phone
912230707806
Fax
Email
Gayatri.Jaiswal@sanofi.com
Source of Monetary or Material Support
Sanofi Synthelabo (India) Limited, A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai – 400093
Primary Sponsor
Name
Sanofi Synthelabo India Limited
Address
A-101, Business Square, Sir Mathuradas Vasanji Marg, Chakala, Andheri (E), Mumbai – 400093
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
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
Sites of Study
No of Sites = 20
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DrSanjay Chatterjee
Apollo Gleneagles Hospital, Kolkata
Dept. of Diabetology, Apollo Gleneagles Hospital, 58, Canal Circular Road, Kolkatta- 700054, West Bengal Kolkata WEST BENGAL
Belgaum Diabetes Centre EC/Belgaum/ Dr. Neeta Deshpande
Approved
Central EC/Chennai/ Dr. V.Mohan
Approved
Central Ethics Committee, Dr. Sharad Pendsey Dr. Jaswant Shah Dr. Pankaj Agarwal Dr. Parag Shah Dr. Dinesh C. Sharma Dr. Archana Sarda Dr. K.D. Modi Dr. Sailesh Lodha Dr. Navneet Agarwal Dr. Chittaranjan Yajnik
Approved
Diabetes Thyroid Hormone Research Institute/EC/Indore/ Dr.Sunil Jain
Approved
IEC of Apollo Gleneagles Hospital Limited, Kolkata
Approved
IEC of Jothydevs Diabetes & Research Centre/Trivandram
Type 1 Diabetes Mellitus, (1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
8.00 Year(s)
Age To
25.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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 Sponsor’s representatives.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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.
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 Outcome
Outcome
TimePoints
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 patients
at the time of visit
Target Sample Size
Total Sample Size="5000" Sample Size from India="400" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
It is an observational non interventional disease registry to assess glycemic control and thee quality of life in type 1 diabetes mellitus aged between 8 and 25 and to evaluate the impact of age-patient related, treatment-related, behaviour and structure of the care related variables in this patient population.
The primary objective of this study 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. The parameters would be evaluated with the use of CRF and tools like quality of life questionarePedsQL and emotional status using Problem Areas in Diabetes (PAID) by patients and their parents.
This is a worldwide cross-sectionalstudy 2012 expected to enroll globally 5000-7000 patients across 21 countries, India will enroll 400 patients across 20 sites.