Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
Eligible age
6–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Rabin Medical Center
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:
- ✓ 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:
You may not qualify if…
- ✕ 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:
Source: ClinicalTrials.gov · NCT06966427 · last updated 2025-05-11