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

NCT06966427 | Recruiting

• 1 other identifier: 0023-25-RMC
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Type 1 diabetes; Type 2 diabetes; Dose guidance system

Outcome Measures

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

  Aafter 6 weeks of intervention period

Secondary Outcomes (2)

• Number of events of glucose readings below 54 mg/dL

  After 6 weeks of intervention period

• Sensor glucose percentage of time in hyperglycemia above 250 mg/dL

  After 6 weeks of intervention period

Other Outcomes (9)

• Glucose Management Indicator (GMI)

  After 6 weeks of intervention period

• Percentage of glucose readings between 70- 180 mg/dl

  After 6 weeks of intervention period

• Change in (Hemoglobin A1c) HbA1C post-study treatment

  After 6 weeks of intervention period

Study Arms (2)

Dosing Guidance System- Group A

EXPERIMENTAL

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

Dosing Guidance System-Group B

EXPERIMENTAL

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

Dosing Guidance System to be used with both time and amount of insulin as input DEVICE

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)

Dosing Guidance System- Group A

Dosing Guidance System to be used with only time of insulin as input DEVICE

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)

Dosing Guidance System-Group B

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
• 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:
• Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir
• 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)

You may not qualify if:

• 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.
• 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 has eGFR \< 45 or is receiving dialysis
• Subject has active proliferative retinopathy
• Active gastroparesis
• Participation in any other interventional study
• Female participant who is pregnant or planning to become pregnant within the planned study duration
• Individuals who are using one of the following types of insulin:
• Intermediate-acting insulin (NPH)
• 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)
• Hypoglycemia unawareness
• Individuals who are treated with intravenous (IV) insulin injections, or a combination of insulin injections and/or IV insulin and insulin pump therapy.
• 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.
• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• DreaMed Diabetes: collaborator

Study Sites (2)

Schneider Children Medical Center of Israel

Petah Tikva, 49202, Israel

NOT YET RECRUITING

University Medical Center of Ljubljana

Ljubljana, Slovenia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, MD

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alona Hamou, Msc

CONTACT

972-545950277; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, single blind, two-arms, multicenter study

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 11, 2025
• Study Start: May 8, 2025
• Primary Completion: May 25, 2026
• Study Completion: May 25, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); SL (1)