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

Primary Purpose

Type1diabetes

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

DreaMed Advisor Pro DSS-MDI algorithm

About this trial

This is an interventional treatment trial for Type1diabetes

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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 (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.
2. 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.

Sites / Locations

schneider children medical center of IsraelRecruiting
Rabin Medical Center- BelinsonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensor glucose percentage of time in hypoglycemia below 54 mg/dl

Sensor glucose percentage of time in hyperglycemia above 250 mg/dl

Secondary Outcome Measures

Percentage of readings within range of 70-180 mg/dl

Change in HbA1C post study treatment

Number of Serious Adverse Events

Full Information

NCT ID

NCT04653961

First Posted

November 28, 2020

Last Updated

March 15, 2023

Sponsor

Rabin Medical Center

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust, DreaMed Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT04653961

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust, DreaMed Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

DreaMed Advisor Pro DSS-MDI algorithm

Intervention Description

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).

Primary Outcome Measure Information:

Title

Sensor glucose percentage of time in hypoglycemia below 54 mg/dl

Time Frame

11 weeks

Title

Sensor glucose percentage of time in hyperglycemia above 250 mg/dl

Time Frame

11 weeks

Secondary Outcome Measure Information:

Title

Percentage of readings within range of 70-180 mg/dl

Time Frame

11 weeks

Title

Change in HbA1C post study treatment

Time Frame

11 weeks

Title

Number of Serious Adverse Events

Time Frame

11 weeks

Other Pre-specified Outcome Measures:

Title

Percentage of readings above 180 mg/dl

Time Frame

11 weeks

Title

Percentage of readings below 70 mg/dl

Time Frame

11 weeks

Title

Mean sensor glucose

Time Frame

11 weeks

Title

Glucose variability

Time Frame

11 weeks

Title

Number of recommendations for changes in the treatment plan per patient

Time Frame

11 weeks

Title

Number of recommendations for changes in the treatment plan per iteration

Time Frame

11 weeks

Title

Number of physician overrides of the study system recommendations

Time Frame

11 weeks

Title

Total insulin dose

Time Frame

11 weeks

Title

The amount of basal insulin dose

Time Frame

11 weeks

Title

The amount of bolus insulin dose

Time Frame

11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moshe Phillip, MD

Phone

972-544-795995

moshe.phillip@phillipmd.com

First Name & Middle Initial & Last Name or Official Title & Degree

Alona Hamou, MSc

Phone

972-3-9253282

alonah@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, MD

Organizational Affiliation

Rabin Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Revital Nimri, MD

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

schneider children medical center of Israel

City

Petach Tikva

ZIP/Postal Code

49202

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, Prof

Phone

972-3-9253282

mosheph@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Revital Nimri, MD

Facility Name

Rabin Medical Center- Belinson

City

Petah-Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Idit Dotan, MD

Phone

972-50-7789310

iditdo@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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