A prospective, randomized, single blind, two-arms, multicenter study. The study aims to assess the safety of a dosing-guided system (DGS) that provides direct advice on insulin dosing recommendations and diabetes management to individuals with diabetes using insulin or starting basal insulin therapy, guided by their continuous glucose monitoring (CGM). The study population will include up to 45 individuals with diabetes, distributed as follows: 15 with Type 1 diabetes (T1D) and 15 with Type 2 diabetes (T2D), both on MDI therapy and 15 with T2D using or starting to use basal insulin. The study will include a 2- to 4-week run-in period followed by a 6-week intervention period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input
any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input
Schneider Children Medical Center of Israel
Petah Tikva, Israel
NOT_YET_RECRUITINGUniversity Medical Center of Ljubljana
Ljubljana, Slovenia
RECRUITINGSensor glucose percentage of time in hypoglycemia below 54 mg/dL
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Time frame: Aafter 6 weeks of intervention period
Number of events of glucose readings below 54 mg/dL
An event is defined as a period of at least 15 minutes of glucose readings below 54 mg/dL. Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Time frame: After 6 weeks of intervention period
Sensor glucose percentage of time in hyperglycemia above 250 mg/dL
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Time frame: After 6 weeks of intervention period
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