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

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

Study Overview

• Status: Recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Device: DreaMed Advisor Pro DSS-MDI algorithm

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moshe Phillip, MD; Phone Number: 972-544-795995; Email: moshe.phillip@phillipmd.com
• Study Contact Backup: Name: Alona Hamou, MSc; Phone Number: 972-3-9253282; Email: alonah@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49202
    • Recruiting
    • Schneider Children Medical Center of Israel
    • Principal Investigator: Revital Nimri, MD
    • Contact: Moshe Phillip, Prof; Phone Number: 972-3-9253282; Email: mosheph@clalit.org.il
  • Petah-Tikva, Israel
    • Recruiting
    • Rabin Medical Center- Belinson
    • Contact: Idit Dotan, MD; Phone Number: 972-50-7789310; Email: iditdo@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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. During the feasibility segment an approval of the study physician (may override the suggestions for safety reasons) will be required prior to sending the recomendations to participants. During the Proof of Concept segment, the recomendations will be sent directly to participants. Participants will be asked to follow the tretment plan for the following 2.5 weeks.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Mean sensor glucose	11 weeks
Percentage of readings above 180 mg/dl	12-16 weeks
Percentage of readings below 70 mg/dl	12-16 weeks
Glucose variability	12-16 weeks
Number of recommendations for changes in the treatment plan per patient	12-16 weeks
Number of recommendations for changes in the treatment plan per iteration	12-16 weeks
Number of physician overrides of the study system recommendations segment 1 only	12-16 weeks
Number of physician overrides of the study system recommendations	12-16 weeks
Total insulin dose	12-16 weeks
The amount of basal insulin dose	12-16 weeks
The amount of bolus insulin dose	12-16 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; DreaMed Diabetes
• Investigators: Study Director: Moshe Phillip, MD, Rabin Medical Center; Principal Investigator: Revital Nimri, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: November 28, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: RMC096020ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No