CTRI/2021/05/033506
Active, not recruiting
Phase 4
Efficacy of a text messaging service for patients with type 2 diabetes to support basal insulin titration - GetFit India Study
Roche Diabetes Care India Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- Roche Diabetes Care India Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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