evaluation of a decision support system for people with diabetes who use multiple daily insulin injections- feasibility and proof of concept studies

Conditions: Type1diabetes

Summary: the study comprises of two segments: a feasibility segment and a proof of concept segment. the study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. participants are people with type 1 or type 2 diabetes treated with multiple daily injections ( mdi) and self monitoring of blood glucose (smbg) or intermittent continuous glucose monitoring (cgm). the study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on dedicated apps), for a total period of 12-16 weeks. the goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by smbg or intermittent cgm


Eligibility criteria:
inclusion criteria: * documented type 1 or type 2 diabetes for at least 1 year prior to study enrolment * aged ≥ 14 years * hba1c of 6.5 ≤ a1c ≤ 10% * using basal-bolus mdi therapy: 1. basal insulin: glargine, degludec, or detemir and up to sum of 72 units of basal insulin 2. bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues * subjects willing to follow study instructions: 1. for smbg users (only for segment 1): measure capillary blood glucose at least 4 times a day . document blood glucose level, insulin delivery, meals and daily activities. wear cgm. 2. for cgm users (fgm with a reader or real-time cgm): use cgm according to manufacture instructions, document insulin delivery, meals and daily activities. * subjects using cgm or smbg that are compatible with data transmission to the study diabetes management system (i.e. for cgm, fgm with a reader). * fasting glucose target is \< = 180 mg/dl (t2d) * subjects have home computer connected to the internet. * subjects have a smart phone compatible with study requirements. * subjects willing and able to sign a written informed consent form. exclusion criteria: * an episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment. * concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety * relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as: * subject has unstable or rapidly progressive renal disease or is receiving dialysis * subject has active proliferative retinopathy * active gastroparesis * subject has loss of kidney function as measured by estimated glomerular filtration rate (egfr) \<45 in the previous 3 months 4. participation in any other interventional study 5. female subject who is pregnant or planning to become pregnant within the planned study duration * subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day. * drug or alcohol abuse.