Type 1 DiabetesNCT04271228
Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1
A study testing DreaMed Advisor Pro in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The DreaMed Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DreaMed Advisor Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Feb 2020to 19 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented Type 1 Diabetes for at least 1 year prior to study enrolment
- Subjects aged 6 - 65 years old
- HbA1c at inclusion ≤ 10%
- Subjects using Insulin pump therapy for at least 4 months
- Subjects using Insulin pump compatible with data transmission to the study Tidepool/Glooko Data Managment System (DMS) - Omnipod, Medtronic
- Subjects using Continuous Glucose Monitoring (CGM) System that is compatible with data transmission to the study Tidepool/Glooko DMS - Dexcom, Libre, Medtronic.
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- Subjects willing to follow study instructions: Use CGM according to manufacture instructions, use the bolus-wizard feature of the insulin pump for every meal and correction boluses.
- Subjects have home PC or MAC connected to the internet.
- Subjects willing and able to sign a written informed consent form.
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 Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). The Advisor Pro 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 pump-setting changes for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.
- Conditions
- Type 1 Diabetes
- Being tested
- DreaMed Advisor Pro
- Keywords
- Decision Support System, Type 1 Diabetes
- 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 Advisor ProDevice
Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
| Study group | Role | What they receive |
|---|---|---|
| DreaMed Advisor Pro | Experimental | Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use Receives: Device: DreaMed Advisor Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Through study completion , an average of 1 year
Secondary outcomes (11)
Percentage of glucose readings within target range of 70-180 mg/dl
Measured: Through study completion, an average of 1 year
Percentage of glucose sensor readings below 54 mg/dl
Measured: Through study completion, an average of 1 year
Percentage of glucose sensor readings above 250 mg/dl
Measured: Through study completion, an average of 1 year
Percentage of glucose sensor readings 70-54 mg/dl
Measured: Through study completion, an average of 1 year
Percentage of glucose sensor readings 180-250 mg/dl
Measured: Through study completion, an average of 1 year
Mean sensor glucose
Measured: Through study completion, an average of 1 year
Glucose variability
Measured: Through study completion, an average of 1 year
Total insulin dose
Measured: Through study completion, an average of 1 year
Total basal insulin dose
Measured: Through study completion, an average of 1 year
Total Bolus insulin dose
Measured: Through study completion, an average of 1 year
Total daily consumed carbohydrates
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Feb 2020
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Revital Nimri, MD, Principal investigator, Schneider Children;s Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271228
- Sponsor's protocol ID
- RMC0525-19ctil
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2020
- Last updated
- 26 Mar 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1
- ClinicalTrials.gov ID
- NCT04271228
- Acronym / sponsor ID
- RMC0525-19ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Decision Support System, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 17 Feb 2020 (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 Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). The Advisor Pro 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 pump-setting changes for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DreaMed Advisor Pro | Experimental | Device: DreaMed Advisor ProUsing the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Documented Type 1 Diabetes for at least 1 year prior to study enrolment
- Subjects aged 6 - 65 years old
- HbA1c at inclusion ≤ 10%
- Subjects using Insulin pump therapy for at least 4 months
- Subjects using Insulin pump compatible with data transmission to the study Tidepool/Glooko Data Managment System (DMS) - Omnipod, Medtronic
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 Advisor ProUsing the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use | Device | DreaMed Advisor Pro |
Primary outcome
HbA1c
Time frame: Through study completion , an average of 1 year
11 secondary outcomes
Percentage of glucose readings within target range of 70-180 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings below 54 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings above 250 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings 70-54 mg/dl
Time frame: Through study completion, an average of 1 year
Percentage of glucose sensor readings 180-250 mg/dl
Time frame: Through study completion, an average of 1 year
Mean sensor glucose
Time frame: Through study completion, an average of 1 year
Glucose variability
Time frame: Through study completion, an average of 1 year
Total insulin dose
Time frame: Through study completion, an average of 1 year
Total basal insulin dose
Time frame: Through study completion, an average of 1 year
Total Bolus insulin dose
Time frame: Through study completion, an average of 1 year
Total daily consumed carbohydrates
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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, MD 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 Advisor Pro 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: finished, as of the sponsor's last update on 26 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Through study completion , an average of 1 year). 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 26 Mar 2024.