Evaluation of a decision support system for diabetes management with insulin injections

Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

This study is testing a new system that helps people with Type 1 or Type 2 diabetes using insulin injections to better manage their treatment and daily activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Rabin Medical Center (Academic / other)
• Locations: 2 sites (Petach Tikva and 1 other locations)
• Trial ID: NCT04653961 on ClinicalTrials.gov

What this trial studies

This study evaluates a decision support system designed to assist individuals with Type 1 or Type 2 diabetes who use multiple daily insulin injections. It consists of two segments: a feasibility segment involving up to 72 participants and a proof of concept segment with up to 40 participants. Participants will record their insulin delivery and daily activities using dedicated apps over a 12-16 week period to assess the safety and effectiveness of the system in adjusting insulin treatment plans. The study aims to improve diabetes management through enhanced monitoring and decision-making support.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14 and older with documented Type 1 or Type 2 diabetes who have been on insulin therapy for at least one year.

Not a fit: Patients who do not use multiple daily insulin injections or have HbA1c levels outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this system could significantly improve insulin management and overall diabetes control for patients using multiple daily injections.

How similar studies have performed: Other studies have shown promise in using decision support systems for diabetes management, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
* Aged ≥ 14 years
* HbA1c of 6.5 ≤ A1c ≤ 10%
* Using basal-bolus MDI therapy:

  1. Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
  2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
* Subjects willing to follow study instructions:

  1. For SMBG users (only for segment 1): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM.
  2. For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
* Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
* Fasting glucose target is \< = 180 mg/dl (T2D)
* Subjects have home computer connected to the internet.
* Subjects have a smart phone compatible with study requirements.
* Subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

* 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.
* Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance 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 is receiving dialysis
  * Subject has active proliferative retinopathy
  * Active gastroparesis
  * Subject has loss of kidney function as measured by estimated Glomerular Filtration Rate (eGFR) \<45 in the previous 3 months 4. Participation in any other interventional study 5. Female subject who is pregnant or planning to become pregnant within the planned study duration
* Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
* Drug or alcohol abuse.

Where this trial is running

Petach Tikva and 1 other locations

• schneider children medical center of Israel — Petach Tikva, Israel (Recruiting)
• Rabin Medical Center- Belinson — Petah-Tikva, Israel (Recruiting)

Study contacts

• Principal investigator: Revital Nimri, MD — Rabin Medical Center
• Study coordinator: Moshe Phillip, MD

Conditions Type1diabetes