ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Agosh Pasricha
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Ajay Patwari
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Ajoy Tewari
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Arun Bajaj
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Arvind Ojha
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Ashish Dengra
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Ashutosh Goyal
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Baig Aziz Mirza
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Chitra Selvan
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Dhruv Singh
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Elizabeth Philip
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Jashvant Shah
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Kapil Patil
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. M C Deepak
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Nadim Akthar Khan
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Pankaj Aneja
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Piyush Desai
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Pramod Gandhi
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Rohit Baijal
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Rohit Kapoor
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Sachin Mittal
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Sandip Kharb
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Sushil Kotru
Approved
ETHICS COMMITTEE JEHANGIR CLINICAL DEVELOPMENT CENTRE PVT, LTD_Dr. Vivek Arya
Approved
Institutional Ethics Committee, Arthur Asirvatham Hospital_Dr. Arthur Asirvatham
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Cross sectional phase
- All male and female adults (with lower legal age limitations (country specific) diagnosed with type 1 or type 2 diabetes, visiting the physician during the recruitment period of the cross-sectional study, up to the number of patients allocated to the physician.
- Written informed consent
2. Longitudinal phase
- Each patient will be asked to enter into the 9-month follow-up period
ExclusionCriteria
Details
1. Cross sectional phase
- Concomitant participation in a clinical trial.
- Current temporary insulin therapy (eg, gestational diabetes, surgery, pancreas cancer)
2. Longitudinal phase
- Concomitant participation in clinical trial.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The global proportion of patients with T2DM treated with insulin
9 months
Secondary Outcome
Outcome
TimePoints
The management of care of patients with type 2 diabetes (T2DM) (CS) will be illustrated
by:
1. The proportion of T2DM patients achieving glycemic targets (HbA1c) as per recommendations of International guidelines and as targeted by the treating physician.
9 Months
Target Sample Size
Total Sample Size="270" Sample Size from India="270" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
IDMPS is a yearly international,
multicenter, non-interventional, observational study to assess current
practices in the management of care of patients with type 1 and type 2 diabetes
mellitus (T1DM and T2DM). Wave 8 of IDMPS is composed of a cross-sectional survey
of 2 weeks’ duration and of a longitudinal 9-month follow-up period. In
this study, each
physician will enter the first 10 patients with T2DM visiting him/her within
the 2-week study period, and the first 5 patients with T1DM visiting him/her in
this timeframe. The patients will then be kept in the study for a 9-month
follow-up period