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

NCT ID: NCT04653961

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-10-31

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

Conditions

Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DreaMed Advisor Pro DSS-MDI algorithm

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

DreaMed Diabetes

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, MD

Role: STUDY_DIRECTOR

Rabin Medical Center

Revital Nimri, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

schneider children medical center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Rabin Medical Center- Belinson

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Moshe Phillip, MD

Role: CONTACT

moshe.phillip@phillipmd.com

972-544-795995

Alona Hamou, MSc

Role: CONTACT

alonah@clalit.org.il

972-3-9253282

Facility Contacts

Moshe Phillip, Prof

Role: primary

mosheph@clalit.org.il

972-3-9253282

Idit Dotan, MD

Role: primary

iditdo@clalit.org.il

972-50-7789310

Other Identifiers

RMC096020ctil

Identifier Type: -

Identifier Source: org_study_id