Evaluation of a dosing guidance system for diabetes management

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

This study is testing a new system that helps people with Type 1 and Type 2 diabetes manage their insulin doses better to see if it improves their blood sugar control.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 6 Years to 75 Years
• Sex: All
• Sponsor: Rabin Medical Center (other)
• Locations: 2 sites (Petah Tikva and 1 other locations)
• Trial ID: NCT06966427 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a dosing guidance system (DGS) designed to assist individuals with Type 1 and Type 2 diabetes in managing their insulin dosing. Participants will be randomly assigned to one of two arms, utilizing the DGS with different input methods for insulin dosing. The study will include a run-in period followed by a six-week intervention phase, during which participants will use continuous glucose monitoring to inform their insulin management. The goal is to provide personalized dosing recommendations to improve diabetes control.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 6 to 75 years with documented Type 1 or Type 2 diabetes who are currently using or starting basal insulin therapy.

Not a fit: Patients who do not use insulin or have an HbA1c greater than 11% may not benefit from this study.

Why it matters

Potential benefit: If successful, this system could enhance insulin management and improve glycemic control for patients with diabetes.

How similar studies have performed: Previous studies have shown promise in using technology for insulin management, suggesting potential success for this approach.

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.

Where this trial is running

Petah Tikva and 1 other locations

• Schneider Children Medical Center of Israel — Petah Tikva, Israel (NOT_YET_RECRUITING)
• University Medical Center of Ljubljana — Ljubljana, Slovenia (RECRUITING)

Study contacts

• Principal investigator: Moshe Phillip, MD — Schneider Children's Medical Center
• Study coordinator: Alona Hamou, Msc

Conditions: Type 1 Diabetes, Type 2 Diabetes, Type 1 diabetes, Type 2 diabetes, Dose guidance system