Messaging Service for Patients with Type 2 Diabetes to support Insulin Titratio

Phase 4

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/05/033506
• Lead Sponsor: Roche Diabetes Care India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Signed written informed consent

- Male and female patients with at least 21 years of age

- Diabetes mellitus type 2

- Initiation of BOT planned including training in diabetes mellitus, BOT therapy, FBG measurement and basal insulin administration

- Possessing and using a mobile phone including SMS and having access to the mobile phone network while at home (self-assessed)

- Ability and willingness to participate in the study, to read and understand all study materials (subject information, informed consent and data protection form, IFU (GetFit flyer for patients), SMS, questionnaires) and to comply with study procedures, including daily BG measurement with the Accu-Chek® BG meter handed out for the study and basal insulin administration as well as timely sending and receiving SMS text messages in the morning and in the evening.

- Subjects should not be on prior insulin therapy except for gestational diabetes or for <1 week.

- Subjects who are on current insulin therapy eg. Prandial insulin, premixed insulin are not eligible for this study.

- Subjects with known impaired awareness of hypoglycaemia with current history of regular hypoglycaemia or hospitalization because of hypoglycaemia in the previous 3 months are not eligible for this study.

- Subject should not be included if they are having significant manifestation of severe diabetes related long-term complications eg. Severe retinopathy, nephropathy requiring dialysis

- Subjects who are pregnant or planning to become pregnant or breastfeeding should be excluded from the study.

- Subjects should not be included if they are having serious or unstable physical or psychological condition rendering the subject unable to understand the nature and the scope of the study and to follow the study procedures.

- Subject having addiction to alcohol or other substance of abuse as assessed by the investigator should not be included.

- Subject should not be included if they having dependency on sponsor or investigator (eg. Co-worker or family member)

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the expectation, experience and satisfaction of users of the InsulinStartTimepoint: Week-06, Week-12

Secondary Outcome Measures

Name	Time	Method
To evaluate medical value of InsulinStart from HCP.Timepoint: week - 06 & Week- 12