A study to describe control of glucose in blood and quality of life for type 1 diabetic adult patients

Not Applicable

Not yet recruiting

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

Registration Number: CTRI/2018/05/013922

Lead Sponsor: Sanofi Synthelabo India Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Male or female.

2 Age greater than or equal to 26 years old.

3 Clinical diagnosis of presumed autoimmune T1DM treated by insulin.

4 Diagnosis of T1DM greater oe equal to 1 year.

5 Glycated hemoglobin value available within 30 days preceding the study visit or planned to be obtained in routine practice within 7 days after the study visit.

7 Signed written informed consent.

Exclusion Criteria

1 Diabetes other than type 1 diabetes eg, type-2 diabetes, secondary diabetes mellitus pancreatic history, drug or chemical-induced diabetes, genetic defects in beta cell function or insulin action.

2 Patients unable to understand the nature and scope of the study, unable to read and write or unlikely to comply with the protocol, eg, inability and unwillingness to complete the PRO questionnaires.

3 Change from pump regimen to multiple insulin injections regimen, or switch from multiple dose injections to pump regimen within the last 3 months preceding study visit.

4 Treatment with oral antidiabetic drugs

thiazolidinedione, sulfonylurea, dipeptidyl peptidase 4 inhibitors at any time from the diagnosis of T1DM.

5 Treatment with any investigational drug within the last 3 months

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the glycemic control in terms of the percentage of patients with T1DM who are at general target of HbA1c less than 7 percent in predefined age groups of 26 to 44 years, 45 to 64 years ,less than 65 years oldTimepoint: This is a cross sectional study and hence the analysis of the outcome would be of the same day as the enrollment date of patient

Secondary Outcome Measures

Name	Time	Method
To evaluate in T1DM adult patients, in the predefined age groups <br/ ><br> <br/ ><br>1 Psychosocial or PRO <br/ ><br>a Hypoglycemia fear. <br/ ><br>b Emotional status. <br/ ><br>c Treatment satisfaction. <br/ ><br>d Health related quality of life. <br/ ><br> <br/ ><br>2 Clinical <br/ ><br>a Glycated hemoglobin levels, fasting plasma glucose FPG, and postprandial plasma glucose PPG. <br/ ><br>b Percentage of patients who are at individualized target HbA1c levels, as established by the physician. <br/ ><br> <br/ ><br>3 Technology usage <br/ ><br> <br/ ><br>Timepoint: This is a cross sectional study and hence the analysis of the outcome would be of the same day as the enrollment date of patient <br/ ><br>