Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies
- Conditions
- Type1diabetes
- Registration Number
- NCT04653961
- Lead Sponsor
- Rabin Medical Center
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
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Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
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Aged ≥ 14 years
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HbA1c of 6.5 ≤ A1c ≤ 10%
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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
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Subjects willing to follow study instructions:
- 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.
- For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
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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).
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Fasting glucose target is < = 180 mg/dl (T2D)
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Subjects have home computer connected to the internet.
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Subjects have a smart phone compatible with study requirements.
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Subjects willing and able to sign a written informed consent form.
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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.
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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
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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
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Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
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Drug or alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sensor glucose percentage of time in hypoglycemia below 54 mg/dl 12-16 weeks Sensor glucose percentage of time in hyperglycemia above 250 mg/dl 12-16 weeks
- Secondary Outcome Measures
Name Time Method Percentage of readings within range of 70-180 mg/dl 12-16 weeks Change in HbA1C post study treatment 12-16 weeks Number of Serious Adverse Events 12-16 weeks
Trial Locations
- Locations (2)
schneider children medical center of Israel
🇮🇱Petach Tikva, Israel
Rabin Medical Center- Belinson
🇮🇱Petah-Tikva, Israel
schneider children medical center of Israel🇮🇱Petach Tikva, IsraelMoshe Phillip, ProfContact972-3-9253282mosheph@clalit.org.ilRevital Nimri, MDPrincipal Investigator