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

NCT ID: NCT06966427

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2026-05-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

endo.digital (Modi algorithm); endo.digital (Modi algorithm)

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DreaMed Diabetes

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

Schneider Children Medical Center of Israel

Petah Tikva, , Israel

Site Status: NOT_YET_RECRUITING

University Medical Center of Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Israel; Slovenia

Central Contacts

Alona Hamou, Msc

Role: CONTACT

alonah@clalit.org.il

972-545950277

Facility Contacts

Moshe Phillip, Prof

Role: primary

mosheph@clalit.org.il

972-3-9253282

Andrej Janež, Prof

Role: primary

andrej.janez@kclj.si

0038615223564

Other Identifiers

0023-25-RMC

Identifier Type: -

Identifier Source: org_study_id