Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

Type1diabetes Clinical Trial

Official title:

Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653961
• Other study ID #: RMC096020ctil
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Rabin Medical Center
• Contact: Moshe Phillip, MD
• Phone: 972-544-795995
• Email: moshe.phillip[@]phillipmd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type1diabetes

Intervention

Device:
• DreaMed Advisor Pro DSS-MDI algorithm
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).

Locations

Country	Name	City	State
Israel	schneider children medical center of Israel	Petach Tikva
Israel	Rabin Medical Center- Belinson	Petah-Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	DreaMed Diabetes, The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of readings above 180 mg/dl		12-16 weeks
Other	Percentage of readings below 70 mg/dl		12-16 weeks
Other	Mean sensor glucose		11 weeks
Other	Glucose variability		12-16 weeks
Other	Number of recommendations for changes in the treatment plan per patient		12-16 weeks
Other	Number of recommendations for changes in the treatment plan per iteration		12-16 weeks
Other	Number of physician overrides of the study system recommendations segment 1 only		12-16 weeks
Other	Number of physician overrides of the study system recommendations		12-16 weeks
Other	Total insulin dose		12-16 weeks
Other	The amount of basal insulin dose		12-16 weeks
Other	The amount of bolus insulin dose		12-16 weeks
Primary	Sensor glucose percentage of time in hypoglycemia below 54 mg/dl		12-16 weeks
Primary	Sensor glucose percentage of time in hyperglycemia above 250 mg/dl		12-16 weeks
Secondary	Percentage of readings within range of 70-180 mg/dl		12-16 weeks
Secondary	Change in HbA1C post study treatment		12-16 weeks
Secondary	Number of Serious Adverse Events		12-16 weeks