Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Roche Diabetes Care India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject has provided his/her signed informed consent to participate in the study. Subject is = 18 years of age Subject is diagnosed with diabetes type 2 and currently on anti-diabetic therapy ± insulin. Subjects most recent HbA1c is above 8% (measured within the last 3 months at local laboratory). Subjects who can read and write in English language and can use smartphone. Subject willing to comply with study procedures.
Exclusion criteria
Exclusion criteria: Subject who has been diagnosed with any clinically significant conditions like infectious disease, major organ system disease such as gastroparesis or renal disease, psychosis or cognitive impairment), at investigator’s discretion will be excluded. Subject who are on chemotherapy and/or radiation therapy (self-reported) will not be considered for this study. Pregnant or lactating women will be excluded from the study. Subject using any other mobile device to monitor blood glucose levels will be excluded. Subject addicted to alcohol or other substance of abuse as assessed by the investigator will be excluded. Subject using any other mobile device to monitor glucose levels will be excluded. Subject with 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 the study procedures will be excluded. Subject with a significant manifestation of severe diabetes related long-term complications e.g., severe retinopathy, neuropathy, nephropathy requiring dialysis will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary - Patient related outcomes PROs– Changes in diabetes distress using Problem Area in Diabetes PAID-20 score Timepoint: Baseline Follow up Visit 3- Week 12 EOS Visit 4- Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The Diabetes Medication System Rating Questionnaire (DMRSQ) ? % of measurements in Range ? Hypoglycemia frequency ? Low Blood Glucose Index ? High Blood Glucose IndexTimepoint: Baseline Follow up visit 2- Week 4 Follow up Visit 3- Week 12 EOS Visit 4- Week 24 Unscheduled visit | — |
Countries
India
Contacts
Public ContactDr Varsha Khatri
Roche Diabetes Care India Pvt Ltd
Outcome results
None listed