Type1diabetesNCT03574558
Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
A study testing MD-Logic Switch Advisor in people with Type1diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components: A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy. B. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- MD-Logic Switch Advisor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2018to 25 Nov 2019
- 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
- The subject has documented Type 1 Diabetes Mellitus, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 3 months prior to study enrolment ( Part A of the study) or at least 6 months (Part B of the study)
- Insulin dose requirement is equal or above 0.5/unit/kg
- The subject age is ≥ 6 years and below 30 years at the time of enrolment
- A1c < 10%
- The subject uses multiple daily injections to deliver insulin and wish to switch to pump therapy (Part A of the study) or the subject uses pump therapy for at least 3 months and is willing to switch to multiple daily injections for the study period (Part B of the study)
- The subject is willing to follow study instructions
- Subject is available for entire study duration
Who cannot join
- 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, or that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency).
- Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or paraenteral glucocorticoids up to 7 days
- Subject has known allergy to medical grade adhesives
- Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening (visit1)
- Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration (or is not using adequate contraceptive methods)
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has a history of one or more episodes of Diabetes Keto-acidosis requiring hospitalization within a 3 months prior to screening
- Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit)
Trial locations and contacts
1 site in 1 country.
About this study
The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components:
- MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy.
- MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections).
Read more
This feasibility study will be divided to two parts:
part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.
- Conditions
- Type1diabetes
- Being tested
- MD-Logic Switch Advisor
- Keywords
- Pump therapy, Multiple Daily Injections (MDI), Decision Support System (DSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-Logic Switch AdvisorDevice
Study algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa
| Study group | Role | What they receive |
|---|---|---|
| MD-Logic Switch Advisor | Experimental | MD-Logic Switch Advisor Algorithm for personalized automated determination of insulin pump settings for subjects with type 1 diabetes switching from MDI to pump therapy and vice versa Receives: Device: MD-Logic Switch Advisor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic below 54 mg/dl
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Aug 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Jaeb Center for Health Research, DreaMed, University of Padova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574558
- Sponsor's protocol ID
- RMC0409-18ctil
- Status last verified
- Jan 2019
- First submitted
- 21 Jun 2018
- Last updated
- 27 Dec 2019
- 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 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
- ClinicalTrials.gov ID
- NCT03574558
- Acronym / sponsor ID
- RMC0409-18ctil
- Conditions
- Type1diabetes
- Keywords
- Pump therapy, Multiple Daily Injections (MDI), Decision Support System (DSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Jaeb Center for Health Research, DreaMed, University of Padova
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 2 Jul 2018 (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 "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components:
- MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy.
- MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections).
This feasibility study will be divided to two parts:
part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MD-Logic Switch Advisor | Experimental | Device: MD-Logic Switch AdvisorMD-Logic Switch Advisor Algorithm for personalized automated determination of insulin pump settings for subjects with type 1 diabetes switching from MDI to pump therapy and vice versa |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- The subject has documented Type 1 Diabetes Mellitus, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 3 months prior to study enrolment ( Part A of the study) or at least 6 months (Part B of the study)
- Insulin dose requirement is equal or above 0.5/unit/kg
- The subject age is ≥ 6 years and below 30 years at the time of enrolment
- A1c < 10%
- The subject uses multiple daily injections to deliver insulin and wish to switch to pump therapy (Part A of the study) or the subject uses pump therapy for at least 3 months and is willing to switch to multiple daily injections for the study period (Part B of the study)
Key exclusion criteria (8 listed)
- 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, or that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency).
- Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or paraenteral glucocorticoids up to 7 days
- Subject has known allergy to medical grade adhesives
- Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening (visit1)
- Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration (or is not using adequate contraceptive methods)
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 |
|---|---|---|
| MD-Logic Switch AdvisorStudy algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa | Device | MD-Logic Switch Advisor |
Primary outcome
Number of hypoglycemic below 54 mg/dl
Time frame: Day 14
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 27 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-Logic Switch Advisor in people with Type1diabetes, 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 7 inclusion and 8 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 27 Dec 2019. 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?
Number of hypoglycemic below 54 mg/dl (time frame: Day 14). 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 27 Dec 2019.