MedPath

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

Not Applicable
Recruiting
Conditions
Type1diabetes
Registration Number
NCT04653961
Lead Sponsor
Rabin Medical Center
Brief Summary

The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM).

The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks.

The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
48
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Sensor glucose percentage of time in hypoglycemia below 54 mg/dl12-16 weeks
Sensor glucose percentage of time in hyperglycemia above 250 mg/dl12-16 weeks
Secondary Outcome Measures
NameTimeMethod
Percentage of readings within range of 70-180 mg/dl12-16 weeks
Change in HbA1C post study treatment12-16 weeks
Number of Serious Adverse Events12-16 weeks

Trial Locations

Locations (2)

schneider children medical center of Israel

🇮🇱

Petach Tikva, Israel

Rabin Medical Center- Belinson

🇮🇱

Petah-Tikva, Israel

schneider children medical center of Israel
🇮🇱Petach Tikva, Israel
Moshe Phillip, Prof
Contact
972-3-9253282
mosheph@clalit.org.il
Revital Nimri, MD
Principal Investigator
© Copyright 2025. All Rights Reserved by MedPath