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RecruitingNCT06966427DGSUpdated May 11, 2025

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

An interventional study of Dosing Guidance System to be used with both time and amount of insulin as input and Dosing Guidance System to be used with only time of insulin as input in Type 1 Diabetes and Type 2 Diabetes, sponsored by Rabin Medical Center. Recruiting at 2 sites in 2 countries. Open to participants aged 6 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
6 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 1 Diabetes
  • Type 2 Diabetes

Keywords

  • Type 1 diabetes
  • Type 2 diabetes
  • Dose guidance system
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 45 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
45 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceDosing 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

    Also known as: endo.digital (Modi algorithm)

  • DeviceDosing 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

    Also known as: endo.digital (Modi algorithm)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Aafter 6 weeks of intervention period

Secondary outcomes

  1. 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

    Time frame: After 6 weeks of intervention period

  2. 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

    Time frame: After 6 weeks of intervention period

Other outcomes

  1. Glucose Management Indicator (GMI)

    Time frame: After 6 weeks of intervention period

  2. 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

    Time frame: After 6 weeks of intervention period

  3. Change in (Hemoglobin A1c) HbA1C post-study treatment

    Time frame: After 6 weeks of intervention period

  4. 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

    Time frame: After 6 weeks of intervention period

  5. Mean sensor glucose

    Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention

    Time frame: After 6 weeks of intervention period

  6. 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

    Time frame: After 6 weeks of intervention period

  7. Time to reach optimal insulin dose

    Time frame: After 6 weeks of intervention period

  8. Total insulin dose and the amount of basal and/or bolus insulin dose

    Time frame: After 6 weeks of intervention period

  9. Device satisfaction questioner

    Time frame: After 6 weeks of intervention period

07

Study locations

1 of 2 sites recruiting
  • Schneider Children Medical Center of Israel
    Petach Tikva, 49202, Israel
    • Moshe Phillip, Prof · Contact · mosheph@clalit.org.il · 972-3-9253282
    • Revital Nimri, MD · Sub investigator
    Not yet recruiting
  • University Medical Center of Ljubljana
    Ljubljana, Slovenia
    • Andrej Janež, Prof · Contact · andrej.janez@kclj.si · 0038615223564
    • Andrej Janež, MD, PHD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06966427
Lead sponsor
Rabin Medical Center
Collaborators
DreaMed Diabetes
Responsible party
Sponsor
First posted
May 11, 2025
Start date
May 8, 2025 (estimated)
Primary completion
May 25, 2026 (estimated)
Completion
May 25, 2026 (estimated)
Last update
May 11, 2025

Study contacts

Alona Hamou, Msc
Contact
alonah@clalit.org.il
972-545950277
Moshe Phillip, MD
principal investigator · Schneider Children's Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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