E11
Conditions
Interventions
Group 1: Study participants who have been randomised to the intervention group will use the Dexcom G7 CGM system for continuous glucose monitoring (CGM) during the 36-week study period to monitor thei
Sponsors
FIDAM GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years and younger than 85 years at time of screening 2. T2DM on basal insulin therapy for =3 months prior to enrollment 3. HbA1c =58 mmol/mol to =97 mmol/mol (=7.5% and =11.0%) 4. Stable diabetes and anti-obesity medication regimen and dose for the past 3 months prior to enrollment 5. According to the investigator's assessment, the participant has the cognitive capacity to provide informed consent, can successfully and safely use a CGM device, adhere to the study protocol, and complete the whole study 6. According to the investigator's assessment, the participant is able and willing to wear, and motivated to engage with, a CGM device, to follow the study procedures as defined within the patient information sheet 7. Informed consent (ICF) has been signed by the participant himself/herself
Exclusion criteria
Exclusion criteria: 1. Regular use of short acting insulin in the past 3 months prior to study enrollment or planning to initiate prandial or short acting insulin 2. Use of real-time CGM or intermittent scanning (Flash) CGM in the past 6 months prior to enrollment. 3. Any surgical procedure for weight loss within the year prior to enrollment or plans for undergoing such bariatric surgery during the study 4. Use of medications known to exacerbate hyperglycemia (current or for more than 14 days in the past 3 months), for example corticosteroids (oral and injectable) or certain psychotropics (antipsychotics, e.g., clozapine, olanzapine, risperidone, and quetiapine) 5. Anticipated acute uses of glucocorticoids (oral, injectable, or intravenous), that will affect glycemic control and impact HbA1c 6. Current or planned use of hydroxyurea (contra-indication for the use of Dexcom G7 CGM system) 7. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator. 8. Concomitant diseases or conditions that in the opinion of the investigator may compromise patient safety including but not limited to cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits 9. Chronic renal insufficiency stage 4 or 5 10. End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 9 months 11. Known severe allergy to medical grade adhesives or a serious skin condition that precludes use of the CGM 12. Current or planned pregnancy 13. Current participation in another interventional study or prior participation in an interventional study in which the participant received active drug within the 90 days prior to screening 14. Lack of capacity to consent due to limited legal capacity or incapacity or legal guardianship 15. Dependence on the sponsor or clinical investigator (e.g. employees of the sponsor or a trial site and their family members)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c levels (long-term glucose levels) from the start of the study to the end of the study (week 36) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Hba1c levels from start of the study to week 12 Hypoglycemic events (occurence of low glucose values) CGM-derived glucose data metrics: proportion of measurements or time i) within the target range (TIR), ii) above the target range (TAR), and iii) below the target range (TBR) Quality of life, general and diabetes-related well-being, and possible burdens due to diabetes (patient questionnaires) | — |
Countries
Germany
Contacts
Public ContactDominic Ehrmann
FIDAM GmbH
Outcome results
None listed