Clinical trial for Type 1 Diabetes
Official title Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
ClinicalTrials.gov ID: NCT06966427
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 75
You may be able to join 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:
- Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
You likely can't join if
- Concomitant diseases/treatment that influence metabolic control or any significant diseases/conditions including psychiatric disorders and substance...
- Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of...
- Subject has unstable or rapidly progressive renal disease or has eGFR \< 45 or is receiving dialysis
- Subject has active proliferative retinopathy
- Active gastroparesis
- Participation in any other treatment study
See the full eligibility 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:
- Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
- 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:
- Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir
- 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)
- 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...
- 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 has eGFR \< 45 or is receiving dialysis
- Subject has active proliferative retinopathy
- Active gastroparesis
- Participation in any other treatment study
- Female participant who is pregnant or planning to become pregnant within the planned study duration
- Individuals who are using one of the following types of insulin:
- Intermediate-acting insulin (NPH)
- 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)
- Hypoglycemia unawareness
- Individuals who are treated with intravenous (IV) insulin injections, or a combination of insulin injections and/or IV insulin and insulin pump therapy.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Petah Tikva, Israel
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Petah Tikva, Israel; Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.