Actively Recruiting
Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
Led by Rabin Medical Center · Updated on 2025-05-11
45
Participants Needed
2
Research Sites
54 weeks
Total Duration
On this page
Sponsors
R
Rabin Medical Center
Lead Sponsor
D
DreaMed Diabetes
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented Type 1 or Type 2 diabetes for at least 6 months
- Age between 6 and 75 years
- HbA1c less than or equal to 11%
- Using basal-bolus multiple daily injection therapy with carbohydrate counting and correction factor or fixed meal dose with correction factor (Segment 1)
- Using or prescribed basal insulin (Segment 2)
- Using basal insulin types including Glargine, Degludec, or Determir
- Using bolus insulin types including regular insulin, rapid analogues, or ultra-rapid analogues
- Willing to use Freestyle Libre continuous glucose monitoring as instructed
- Able to document insulin delivery, meals, and daily activities
- Has a compatible smartphone for study requirements
- Willing and able to sign informed consent
- Willing to use bolus calculator for insulin dosing (only for Segment 1)
You will not qualify if you...
- Having diseases or treatments affecting metabolic control or significant conditions including psychiatric disorders or substance abuse that may affect study completion or safety
- Severe organ disorders such as diabetic nephropathy, retinopathy, foot syndrome, unstable or rapidly progressive renal disease, eGFR less than 45, or dialysis
- Active proliferative retinopathy or gastroparesis
- Participation in another interventional study
- Pregnancy or planning pregnancy during the study
- Using intermediate-acting insulin (NPH), mixed insulin premixes, or inhaled insulin
- Hypoglycemia unawareness
- Treatment with intravenous insulin injections or insulin pump therapy
- Extensive skin changes or diseases interfering with device placement or glucose measurement accuracy
- Recent diabetic keto-acidosis or severe hypoglycemia causing seizure or unconsciousness within one month prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Schneider Children Medical Center of Israel
Petah Tikva, Israel, 49202
Not Yet Recruiting
2
University Medical Center of Ljubljana
Ljubljana, Slovenia
Actively Recruiting
Research Team
A
Alona Hamou, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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