Type 1 DiabetesEndo digitalNCT05610722
Use of Insulin Adjustment Device DreaMed Endo Digital During Routine Clinical Use for Subjects With Diabetes Type 1
A study testing DreaMed Endo Digital in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The DreaMed Endo.Digital is indicated for use by healthcare professionals treating individuals with Type 1 Diabetes (T1D) who use insulin pump or multiple daily injections (MDI) as their insulin delivery therapy and monitor their glucose levels by using Continuous Glucose Monitoring (CGM) or Flash Glucose monitoring… Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DreaMed Endo Digital
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Nov 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Documented T1D for at least 6 months prior to study enrolment
- Subjects aged 6 years and above and below 30 years
- HbA1c at inclusion ≤ 10%
- Subjects using Insulin pump therapy for at least 3 months OR using basal-bolus MDI therapy either carbohydrate counting or using sliding scale for meal bolus:
- Basal insulin: Glargine, Degludec, or Detemir and up to sum of 72 units of basal insulin
- Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
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- Subjects willing to follow study instructions:
- For SMBG users: measure capillary blood glucose at least 3 times a day (preferable before each meal). Document blood glucose level, insulin delivery and meals using the App for MDI users and bolus pump calculator for pump users.
- For CGM users: Use CGM according to manufacture instructions, document insulin delivery and meals using the App for MDI users and bolus pump calculator for pump users.
Who cannot join
- 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 patient's 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
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- Participation in any other interventional study
- 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.
- Known or suspected allergy to trial products
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
The DreaMed Endo.Digital is indicated for use by healthcare professionals treating individuals with Type 1 Diabetes (T1D) who use insulin pump or multiple daily injections (MDI) as their insulin delivery therapy and monitor their glucose levels by using Continuous Glucose Monitoring (CGM) or Flash Glucose monitoring (FGM), or SMBG above the age of 6 years old and below 30 years.
DreaMed Endo.DigitalTM is indicated for use by healthcare professionals when analyzing CGM/SMBG and pump or MDI data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); or MDI settings for basal rate, carbohydrate ratio (CR), and correction factor (CF) or Sliding Scale without considering the full clinical status of a particular patient. DreaMed Endo.DigitalTM does not replace clinical judgement.
Read more
The proposed study is an open label, interventional study that will include up to 500 participants with type 1 diabetes using insulin pumps or MDI therapy and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring or SMBG.
The proposed study will be 12 months, therefore will include 5 routine clinic visits.
At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit.
In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. At study completion, glycemic control will be evaluated by measured HbA1c and the data obtained from the participant devices and CGM/glucometer metrics, or Endo.Digital App data for MDI users.
- Conditions
- Type 1 Diabetes
- Being tested
- DreaMed Endo Digital
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreaMed Endo DigitalDevice
The DreaMed Endo.Digital uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5-minute data collection and analysis, the algorithm learns and suggests insulin dose adjustments and behavioral tips for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals.
| Study group | Role | What they receive |
|---|---|---|
| DreaMed Endo Digital | Other | At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit.
In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits: P1-up to P8). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. Receives: Device: DreaMed Endo Digital |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12 month
Secondary outcomes (1)
Percentage of sensor readings below 54 mg/dl
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start6 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Internal decision
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DreaMed Diabetes
- Responsible party
- Sponsor
- Investigators
- Revital Nimri, Dr, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610722
- Sponsor's protocol ID
- RMC057522CTIL
- Acronym
- Endo digital
- Status last verified
- Apr 2024
- First submitted
- 3 Nov 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Insulin Adjustment Device DreaMed Endo Digital During Routine Clinical Use for Subjects With Diabetes Type 1
- ClinicalTrials.gov ID
- NCT05610722
- Acronym / sponsor ID
- Endo digital / RMC057522CTIL
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- DreaMed Diabetes
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 9 Nov 2022 (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.
The DreaMed Endo.Digital is indicated for use by healthcare professionals treating individuals with Type 1 Diabetes (T1D) who use insulin pump or multiple daily injections (MDI) as their insulin delivery therapy and monitor their glucose levels by using Continuous Glucose Monitoring (CGM) or Flash Glucose monitoring (FGM), or SMBG above the age of 6 years old and below 30 years.
DreaMed Endo.DigitalTM is indicated for use by healthcare professionals when analyzing CGM/SMBG and pump or MDI data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); or MDI settings for basal rate, carbohydrate ratio (CR), and correction factor (CF) or Sliding Scale without considering the full clinical status of a particular patient. DreaMed Endo.DigitalTM does not replace clinical judgement.
The proposed study is an open label, interventional study that will include up to 500 participants with type 1 diabetes using insulin pumps or MDI therapy and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring or SMBG.
The proposed study will be 12 months, therefore will include 5 routine clinic visits.
At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit.
In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. At study completion, glycemic control will be evaluated by measured HbA1c and the data obtained from the participant devices and CGM/glucometer metrics, or Endo.Digital App data for MDI users.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DreaMed Endo Digital | Other | Device: DreaMed Endo DigitalAt each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit. In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits: P1-up to P8). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Documented T1D for at least 6 months prior to study enrolment
- Subjects aged 6 years and above and below 30 years
- HbA1c at inclusion ≤ 10%
- Subjects using Insulin pump therapy for at least 3 months OR using basal-bolus MDI therapy either carbohydrate counting or using sliding scale for meal bolus:
- Subjects willing to follow study instructions:
Key exclusion criteria (11 listed)
- 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 patient's 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 subject who is pregnant or planning to become pregnant within the planned study duration
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 |
|---|---|---|
| DreaMed Endo DigitalThe DreaMed Endo.Digital uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5-minute data collection and analysis, the algorithm learns and suggests insulin dose adjustments and behavioral tips for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals. | Device | DreaMed Endo Digital |
Primary outcome
HbA1c
Time frame: 12 month
1 secondary outcome
Percentage of sensor readings below 54 mg/dl
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Internal decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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. This study is not recruiting at the moment.
Revital Nimri, Dr principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DreaMed Endo Digital in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study was stopped early (reason given: Internal decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 month). 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 12 Apr 2024.