Diabetes Diabetes
Conditions
Interventions
A FreeStyle Libre X sensor is applied on the back of the upper arm of the participant to collect raw glucose and ketone data continuously for 15 days. The sensor is used in a masked mode.
Sponsors
Maeda Masatami
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged at least 2 years old at the time of research enrolment. 2.Diagnosis of either type 1 or type 2 diabetes mellitus. 3.If Type 2 diabetes mellitus, then must be aged at least 18 years old at time of research enrolment. 4.If Type 2 diabetes mellitus, then must be in at least one of the following groups: a.Multiple Daily Injection (MDI) therapy* b.On SGLT2 inhibitor medications and basal insulin therapy 5.In the Principal Investigator's opinion, the participant is willing to wear the sensor, follow the research instructions, and perform all the research tasks. * In this research, MDI therapy is defined as insulin injection therapy at least twice a day.
Exclusion criteria
Exclusion criteria: 1.Aged below 18 years with Type 1 diabetes and on SGLT2 inhibitor medications. 2.A female participant who is pregnant at enrolment or becomes pregnant during the research. 3.A member of the research staff at the medical research site. 4.Self-reports that they are currently practicing a ketogenic or low carbohydrate diet. 5.Has either a magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment scheduled to occur during the research period. 6. Has a known (or suspected) allergy to medical grade adhesives at enrolment in the research. 7.In the Principal Investigator's opinion the participant has concomitant medical condition(s) which could interfere with the research or present a risk to the safety or welfare of the participant or research staff. 8.Currently participating in another clinical trial/research which may affect glucose or ketone management or will do so during the research. 9.Has a pacemaker or any other neurostimulator. 10.Is unsuitable for participation due to any other cause as determined by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the frequency of ketosis episodes (including diabetic ketoacidosis, DKA) in adult and paediatric people living with diabetes. | — |
Secondary
| Measure | Time frame |
|---|---|
| All disease (AEs) including severe hypoglycaemia, hyperosmolar hyperglycaemic state (HHS), significant ketosis and diabetic ketoacidosis (DKA) experienced during the research will be collected. | — |
Contacts
Public ContactMasatami Maeda
EPS Corporation
Outcome results
None listed