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.
Documented T1D or T2D, for at least 6 months
Aged ≥ 6 years ≤ 75 years
HbA1c ≤ 11%
Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
Concomitant diseases/treatment that influence metabolic control or any significant diseases/conditions including psychiatric disorders and substance abuse or drug or alcohol abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety.
Subject has unstable or rapidly progressive renal disease or has eGFR < 45 or is receiving dialysis
Subject has active proliferative retinopathy
Active gastroparesis
Parallel
Dosing Guidance System to be used with both time and amount of insulin as input
DeviceAny insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input
Dosing Guidance System to be used with only time of insulin as input
Deviceany insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input
Sensor 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
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
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
Glucose Management Indicator (GMI)
Percentage of glucose readings between 70- 180 mg/dl
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Change in (Hemoglobin A1c) HbA1C post-study treatment
Percentage of glucose readings below 70 mg/dl
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
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Rabin Medical Center
Lead sponsor
DreaMed Diabetes
Collaborator
