Type 1 DiabetesDGSNCT06966427
Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
A study testing Dosing Guidance System to be used with both time and amount of insulin as input and Dosing Guidance System to be used with only time of insulin as input in people with Type 1 Diabetes and Type 2 Diabetes, run by Rabin Medical Center at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Dosing Guidance System to be used with both time and amount of insulin as input and Dosing Guidance System to be used with only time of insulin as input
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 May 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
- 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 interventional study
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- 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:
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Israel1 site, 1 recruiting
- Not yet recruiting
Schneider Children Medical Center of Israel
Petah Tikva, 49202
Moshe Phillip, Prof, 972-3-9253282, mosheph@clalit.org.il
Revital Nimri, MD
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center of Ljubljana
Ljubljana
Andrej Janež, Prof, 0038615223564, andrej.janez@kclj.si
Andrej Janež, MD, PHD
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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Dosing Guidance System to be used with both time and amount of insulin as input, Dosing Guidance System to be used with only time of insulin as input
- Keywords
- Type 1 diabetes, Type 2 diabetes, Dose guidance system
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosing Guidance System to be used with both time and amount of insulin as inputDevice
Also called endo.digital (Modi algorithm)
Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input
Dosing Guidance System to be used with only time of insulin as inputDevice
Also called endo.digital (Modi algorithm)
any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input
| Study group | Role | What they receive |
|---|---|---|
| Dosing Guidance System- Group A | Experimental | Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input. Receives: Device: Dosing Guidance System to be used with both time and amount of insulin as input |
| Dosing Guidance System-Group B | Experimental | Any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input Receives: Device: Dosing Guidance System to be used with only time of insulin as input |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor glucose percentage of time in hypoglycemia below 54 mg/dL
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Measured: Aafter 6 weeks of intervention period
Secondary outcomes (2)
Number of events of glucose readings below 54 mg/dL
An event is defined as a period of at least 15 minutes of glucose readings below 54 mg/dL.
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Measured: After 6 weeks of intervention period
Sensor glucose percentage of time in hyperglycemia above 250 mg/dL
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
Measured: After 6 weeks of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start8 May 2025 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, single blind, two-arms, multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DreaMed Diabetes
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, MD, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966427
- Sponsor's protocol ID
- 0023-25-RMC
- Acronym
- DGS
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
- ClinicalTrials.gov ID
- NCT06966427
- Acronym / sponsor ID
- DGS / 0023-25-RMC
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Type 1 diabetes, Type 2 diabetes, Dose guidance system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- DreaMed Diabetes
- Study start
- 8 May 2025 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, randomized, single blind, two-arms, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Dosing Guidance System- Group A | Experimental | Device: Dosing Guidance System to be used with both time and amount of insulin as inputAny insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input. |
| Dosing Guidance System-Group B | Experimental | Device: Dosing Guidance System to be used with only time of insulin as inputAny insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- For Segment 2: Using or prescribed basal insulin
Key exclusion criteria (15 listed)
- 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.
- Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
- Participation in any other interventional 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosing Guidance System to be used with both time and amount of insulin as inputAlso: endo.digital (Modi algorithm)Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input | Device | Dosing Guidance System- Group A |
| Dosing Guidance System to be used with only time of insulin as inputAlso: endo.digital (Modi algorithm)any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input | Device | Dosing Guidance System-Group B |
Primary outcome
Sensor glucose percentage of time in hypoglycemia below 54 mg/dL
Time frame: Aafter 6 weeks of intervention period
Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention
2 secondary outcomes
Number of events of glucose readings below 54 mg/dL
Time frame: After 6 weeks of intervention period
Sensor glucose percentage of time in hyperglycemia above 250 mg/dL
Time frame: After 6 weeks of intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moshe Phillip, MD principal investigator
Schneider Children's Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosing Guidance System to be used with both time and amount of insulin as input and Dosing Guidance System to be used with only time of insulin as input in people with Type 1 Diabetes and Type 2 Diabetes, run by Rabin Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alona Hamou, Msc (972-545950277, alonah@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor glucose percentage of time in hypoglycemia below 54 mg/dL (time frame: Aafter 6 weeks of intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.