Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections (DGS)

A prospective, randomized, single blind, two-arms, multicenter study. The study aims to assess the safety of a dosing-guided system (DGS) that provides direct advice on insulin dosing recommendations and diabetes management to individuals with diabetes using insulin or starting basal insulin therapy, guided by their continuous glucose monitoring (CGM).

The study population will include up to 45 individuals with diabetes, distributed as follows: 15 with Type 1 diabetes (T1D) and 15 with Type 2 diabetes (T2D), both on MDI therapy and 15 with T2D using or starting to use basal insulin.

The study will include a 2- to 4-week run-in period followed by a 6-week intervention period.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: Dosing Guidance System to be used with both time and amount of insulin as input; Device: Dosing Guidance System to be used with only time of insulin as input

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alona Hamou, Msc; Phone Number: 972-545950277; Email: alonah@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49202
    • Not yet recruiting
    • Schneider Children Medical Center of Israel
    • Contact: Moshe Phillip, Prof; Phone Number: 972-3-9253282; Email: mosheph@clalit.org.il
    • Sub-Investigator: Revital Nimri, MD
• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • University Medical Center of Ljubljana
    • Principal Investigator: Andrej Janez, MD, PhD
    • Contact: Andrej Janež, Prof; Phone Number: 0038615223564; Email: andrej.janez@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented T1D or T2D, for at least 6 months
• Aged ≥ 6 years ≤ 75 years
• HbA1c ≤ 11%

• For Segment 1: Using basal-bolus MDI therapy, i.e. basal insulin and a bolus that is either:

  1. Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
  2. Fix dose for meal / meal estimation with CF
• For Segment 2: Using or prescribed basal insulin

• Participants using the following type of insulin as directed in the instructions for use:

  1. Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir
  2. Bolus insulin: regular insulin, rapid analogues (Insulin Aspart, Insulin Glulisine, Insulin Lispro) or ultra-rapid analogues (Fiasp, Lyumjev)
• Participants willing to use FreesStyle Libre CGM according to manufacturer instructions, document insulin delivery, meals, and daily activities.
• Participants have a smartphone compatible with study requirements.
• Participants are willing and able to sign a written informed consent form to use their data.
• Participants are willing to use the bolus calculator for insulin dosing (only for segment 1)

Exclusion Criteria:

1. Concomitant diseases/treatment that influence metabolic control or any significant diseases/conditions including psychiatric disorders and substance abuse or drug or alcohol abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety.

2. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

   1. Subject has unstable or rapidly progressive renal disease or has eGFR < 45 or is receiving dialysis
   2. Subject has active proliferative retinopathy
   3. Active gastroparesis
3. Participation in any other interventional study
4. Female participant who is pregnant or planning to become pregnant within the planned study duration

5. Individuals who are using one of the following types of insulin:

   1. Intermediate-acting insulin (NPH)
   2. Mixed insulin like:

   i. Premix NPH/ Regular (e.g. Humalin 70/30, Novolog 70/30) ii. Premix analogs (e.g, Novolog mix 70/30, Hu,alog mix 75, 25, Humalog Mix 50/50) c. Inhale insulin (e.g. Afrezza)

6. Hypoglycemia unawareness
7. Individuals who are treated with intravenous (IV) insulin injections, or a combination of insulin injections and/or IV insulin and insulin pump therapy.
8. Individuals who have extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Guidance System- Group A; Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input.	Device: Dosing Guidance System to be used with both time and amount of insulin as input; Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input; Other Names: endo.digital (Modi algorithm)
Experimental: Dosing Guidance System-Group B; Any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input	Device: Dosing Guidance System to be used with only time of insulin as input; any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input; Other Names: endo.digital (Modi algorithm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor glucose percentage of time in hypoglycemia below 54 mg/dL	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	Aafter 6 weeks of intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of events of glucose readings below 54 mg/dL	An event is defined as a period of at least 15 minutes of glucose readings below 54 mg/dL. Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period
Sensor glucose percentage of time in hyperglycemia above 250 mg/dL	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Management Indicator (GMI)		After 6 weeks of intervention period
Percentage of glucose readings between 70- 180 mg/dl	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period
Change in (Hemoglobin A1c) HbA1C post-study treatment		After 6 weeks of intervention period
Percentage of glucose readings below 70 mg/dl	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period
Mean sensor glucose	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period
Glucose variability measured by Standard Deviation (SD) and CV%	Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention	After 6 weeks of intervention period
Time to reach optimal insulin dose		After 6 weeks of intervention period
Total insulin dose and the amount of basal and/or bolus insulin dose		After 6 weeks of intervention period
Device satisfaction questioner		After 6 weeks of intervention period

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: DreaMed Diabetes
• Investigators: Principal Investigator: Moshe Phillip, MD, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 8, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Type 1 diabetes; Dose guidance system
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 0023-25-RMC

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