Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Routine BOT therapy supported by a text messaging service: Patient needs to respond to SMS from the messaging service. In particular, the patient needs to enter Fasting Blood Glucose in the morning an
Sponsors
Roche Diabetes Care GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Male and female patients with at least 21 years of age 3. Diabetes mellitus type 2 4. Initiation of BOT planned including training in diabetes mellitus, BOT therapy, FBG measurement and basal insulin administration 5. Individual FBG target range set to 140 mg/dL (7.8 mmol/l) or lower by the investigator as described by BOT guidelines 6. HbA1c =7.5% (58,5 mmol/mol), determined within the previous 3 months 7. Possessing and using a mobile phone including SMS messaging and having access to the mobile phone network while at home (self-assessed) 8. Ability and willingness to participate in the study, to read and understand all study materials (subject information, informed consent and data protection form, IFU, SMS text messages, questionnaires) and to comply with study procedures, including daily BG measurement with the Accu-Chek® BG meter handed out for the study and administration of once-daily, long-acting insulin as well as timely sending and receiving SMS text messages in the morning and in the evening and blood draws for repeated HbA1c determination
Exclusion criteria
Exclusion criteria: 1. Prior insulin therapy except for gestational diabetes or for < 1 week 2. Current insulin therapy, e.g. prandial insulin, premixed insulin 3. Known impaired awareness of hypoglycemia with current history of regular hypoglycemia or hospitalization(s) because of severe hypoglycemia in the previous 3 months 4. Significant manifestation of severe diabetes-related long-term complications e.g. severe retinopathy, neuropathy, nephropathy requiring dialysis 5. Pregnant or planning to become pregnant or breastfeeding 6. Legal incompetence or limited legal competence 7. Serious or unstable chronic physical or psychological condition rendering the subject unable to understand the nature and the scope of the study and to follow the study procedures 8. Addiction to alcohol or other substance(s) of abuse as assessed by the investigator 9. Dependency on sponsor or Investigator (e.g. co-worker or family member)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with FBG stable in their individual target range after completion of GetFit supported basal insulin titration at latest, measured using [method] calculated using system data at Visit 4 (week 16 [±14 days]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/03/2021: 1. Number of days until the FBG target range was reached, calculated using system data, timepoint individual for each patient 2. Change in HbA1c measured using blood sample analysis at Visit 4 compared to baseline (pre-post) 3. HbA1c measured using blood sample analysis at visit 4 4. Change in FBG (blood glucose self-measurement) at Visit 4 compared to baseline (pre-post) 5. Total daily basal insulin dose at Visit 4, calculated using system data at timepoint individual for each patient 6. Number of hypoglycemic events, i.e., self-monitored BG < 70 mg/dl (3.9 mmol/l) from baseline to visit 4 7. Number of additional contacts (visits and telephone) between subject and HCP and other study staff concerning the use of GetFit and the insulin titration including FBG measurement and insulin administration, calculated from baseline to Visit 4 8. Adherence to the requests of the GetFit service: 8.1. Response rate to the GetFit service, specified by percent of SMS answered by the subject within the expected time between baseline and Visit 4 8.2. Response time from receiving the SMS from the GetFit service to the SMS sent by the subject between baseline and Visit 4 9. Correctness of FBG values entered into the SMS compared to the values stored in the BG meter, measured using system and BG meter data from baseline to Visit 4 10. Compliance with the advised insulin doses calculated using system data from baseline to Visit 4 11. Change in diabetes distress measured using Diabetes Distress Scale (DDS) at Visit 4 compared to baseline (pre-post) 12. Change in anxiety and depression measured using Hospital Anxiety and Depression Scale (HADS) at Visit 4 compared to baseline (pre-post) 13. Change in | — |
Countries
Germany
Contacts
Public ContactClinical Trials
Outcome results
None listed