Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility Study

Study Overview
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Brief Summary
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An open label, prospective study that will include up to 48 subjects with Type 1 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 a 8 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 12-14 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

Official Title
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Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility Study

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: DreaMed Advisor Pro DSS-MDI algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment Aged ≥ 14 years HbA1c of 7 ≤ A1c ≤ 10% Using basal-bolus MDI therapy: Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues Subjects willing to follow study instructions: For SMBG users (FGM with a reader): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM. For CGM users: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro Decision Support System-MDI algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 2.5 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan. | Device: DreaMed Advisor Pro DSS-MDI algorithm<br>* The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor glucose percentage of time in hypoglycemia below 54 mg/dl |  | 11 weeks | 
| Sensor glucose percentage of time in hyperglycemia above 250 mg/dl |  | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of readings within range of 70-180 mg/dl |  | 11 weeks | 
| Change in HbA1C post study treatment |  | 11 weeks | 
| Number of Serious Adverse Events |  | 11 weeks |