Insulin-dependent Diabetes MellitusNCT04043260
DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
A study testing Advisor Pro in people with Insulin-dependent Diabetes Mellitus and Diabetes Mellitus, Type 1, run by DreaMed Diabetes at 1 site in Israel.
Trial summary
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin-dependent Diabetes Mellitus, Diabetes Mellitus, Type 1
- What is being tested?
- Advisor Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Nov 2019to 30 Apr 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented T1D for at least 1 year prior to study enrolment
- Subjects aged 18 - 65 years old
- A1c at inclusion ≤ 10%
- Subjects using basal-bolus MDI therapy:
- Basal insulin: Glargine, Degludec, or Determir
- Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
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- Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
- BMI < 28 kg/m2
- Subjects willing to follow study instructions:
- For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
- For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
- Subjects have connection to the internet at home.
- Subjects have a smartphone compatible with study requirements
- 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 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 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.
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).
The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.
- Being tested
- Advisor Pro
- Keywords
- Diabetes Type 1, Multiple Daily Injections
- 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.
Advisor ProDevice
The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 3 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan. Receives: Device: Advisor Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of readings below 54 mg/dl
Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.
Measured: 9 weeks
Secondary outcomes (2)
Percentage of readings within range of 70-180 mg/dl
Measured: 9 weeks
Change in HbA1C post study treatment
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start27 Nov 2019
- Primary completion28 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-dependent Diabetes MellitusStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- DreaMed Diabetes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yael Shtrit, Study director, DreaMed Diabetes Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043260
- Sponsor's protocol ID
- CR-0998
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2019
- Last updated
- 17 Aug 2021
- 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 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin
- ClinicalTrials.gov ID
- NCT04043260
- Acronym / sponsor ID
- CR-0998
- Keywords
- Diabetes Type 1, Multiple Daily Injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- DreaMed DiabetesIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 2 Aug 2019 (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 multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).
The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Advisor ProSubject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 3 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Documented T1D for at least 1 year prior to study enrolment
- Subjects aged 18 - 65 years old
- A1c at inclusion ≤ 10%
- Subjects using basal-bolus MDI therapy:
- Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
Key exclusion criteria (10 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 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 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 |
|---|---|---|
| Advisor ProThe DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets). | Device | Intervention |
Primary outcome
Percentage of readings below 54 mg/dl
Time frame: 9 weeks
Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.
2 secondary outcomes
Percentage of readings within range of 70-180 mg/dl
Time frame: 9 weeks
Change in HbA1C post study treatment
Time frame: 9 weeks
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 17 Aug 2021.
- 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. This study is not recruiting at the moment.
Yael Shtrit study director
DreaMed Diabetes Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advisor Pro in people with Insulin-dependent Diabetes Mellitus and Diabetes Mellitus, Type 1, run by DreaMed Diabetes 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 14 inclusion and 10 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 17 Aug 2021. 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?
Percentage of readings below 54 mg/dl (time frame: 9 weeks). 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 17 Aug 2021.