Type 1 DiabetesNCT04014569
Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study
A study testing MPSA Algorithm in people with Type 1 Diabetes and Multiple Daily Injections, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Type 1 Diabetes, Multiple Daily Injections
- What is being tested?
- MPSA Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- 2 May 2018to 1 Sep 2020
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Documented T1D for at least 1 year prior to study enrolment
- Subjects aged ≥ 14 years and up to 30 years
- A1c at inclusion ≥ 7 % and ≤ 10%
- Using MDI of Basal/bolus therapy - basal insulin either Glargine/Lantus or Tregludec insulin and bolus short acting insulin analogs either aspart/Novorapid or Lispro/Humalog
- Using SMBG or flash glucose monitoring (FGM/Libre) without using glucose trends
- BMI SDS - below the 97th percentile for age
- Subjects willing to follow study instructions
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
- Participation in any other interventional study
- Known or suspected allergy to trial products
- Female subject who is pregnant or planning to become pregnant within the planned study duration
- Subject needs to travel by air during the study duration
Trial locations and contacts
1 site in 1 country.
About this study
The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG.
The study will focus on the development, validation and eventually testing of the MPSA algorithm use. The major objective of the project is to develop an algorithm that will be able to optimize treatment plan parameters of MDI patients who use SMBG as glucose monitoring method. The clinical study has two segments. Segment A is an observational study needed for the development of the algorithm (this segment was already completed at the time of the registration) and Segment B is a proof of concept interventional study to validate the algorithm's Safety and Efficacy.
Up to 20 patients using MDI and SMBG or Flash Glucose Monitoring (FGM) without using glucose trends will be enrolled to this proof of concept study. The study will evaluate the algorithm use for a period of 11 weeks. Post screening, patients will undergo a two weeks run-in period while using MDI and SMBG or FGM (patients that do not use FGM will be provided with blinded Libre Flash to be used during the run-in period and 2 weeks prior to arriving to end of study visit). Then, patients will undergo insulin treatment plan changes every week for 7 weeks. At the first 3 weeks insulin dose adjustments will be done for basal insulin dose only, week 4 will be without changes, and in the next 3 weeks the carbohydrate ratio will be amended. No recommendations will be given during the last two weeks of the study. These two weeks will be used for data analysis. Each recommendation of the Advisor will be approved by a physician before implementation. Glucose outcomes will be evaluated comparing the two weeks run-in period to the last two weeks of the study.
- Conditions
- Type 1 Diabetes, Multiple Daily Injections
- Being tested
- MPSA Algorithm
- 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.
MPSA AlgorithmDevice
Insulin dosing will be adjusted using the MPSA Algorithm
| Study group | Role | What they receive |
|---|---|---|
| MPSA Algorithm | Experimental | Insulin dosing will be adjusted using the MPSA algorithm Receives: Device: MPSA Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of sensor glucose readings within range of 70-180 mg/dl
Measured: Final visit (day 42)
Secondary outcomes (4)
Percentage of sensor glucose readings below 54 mg/dl
Measured: Final visit (day 42)
HbA1c
Measured: Final visit (day 42)
Number of Severe Hypoglycemia events
Measured: Final visit (day 42)
Number of Diabetic Ketoacidosis events
Measured: Final visit (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start2 May 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Investigators 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DreaMed, Harvard University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014569
- Sponsor's protocol ID
- RMC018718ctil
- Status last verified
- Nov 2020
- First submitted
- 9 Jul 2019
- Last updated
- 1 Dec 2020
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04014569
- Acronym / sponsor ID
- RMC018718ctil
- Conditions
- Type 1 Diabetes, Multiple Daily Injections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- DreaMed, Harvard University
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 Jul 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.
The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG.
The study will focus on the development, validation and eventually testing of the MPSA algorithm use. The major objective of the project is to develop an algorithm that will be able to optimize treatment plan parameters of MDI patients who use SMBG as glucose monitoring method. The clinical study has two segments. Segment A is an observational study needed for the development of the algorithm (this segment was already completed at the time of the registration) and Segment B is a proof of concept interventional study to validate the algorithm's Safety and Efficacy.
Up to 20 patients using MDI and SMBG or Flash Glucose Monitoring (FGM) without using glucose trends will be enrolled to this proof of concept study. The study will evaluate the algorithm use for a period of 11 weeks. Post screening, patients will undergo a two weeks run-in period while using MDI and SMBG or FGM (patients that do not use FGM will be provided with blinded Libre Flash to be used during the run-in period and 2 weeks prior to arriving to end of study visit). Then, patients will undergo insulin treatment plan changes every week for 7 weeks. At the first 3 weeks insulin dose adjustments will be done for basal insulin dose only, week 4 will be without changes, and in the next 3 weeks the carbohydrate ratio will be amended. No recommendations will be given during the last two weeks of the study. These two weeks will be used for data analysis. Each recommendation of the Advisor will be approved by a physician before implementation. Glucose outcomes will be evaluated comparing the two weeks run-in period to the last two weeks of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPSA Algorithm | Experimental | Device: MPSA AlgorithmInsulin dosing will be adjusted using the MPSA algorithm |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Documented T1D for at least 1 year prior to study enrolment
- Subjects aged ≥ 14 years and up to 30 years
- A1c at inclusion ≥ 7 % and ≤ 10%
- Using MDI of Basal/bolus therapy - basal insulin either Glargine/Lantus or Tregludec insulin and bolus short acting insulin analogs either aspart/Novorapid or Lispro/Humalog
- Using SMBG or flash glucose monitoring (FGM/Libre) without using glucose trends
Key exclusion criteria (6 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
- Participation in any other interventional study
- Known or suspected allergy to trial products
- 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 |
|---|---|---|
| MPSA AlgorithmInsulin dosing will be adjusted using the MPSA Algorithm | Device | MPSA Algorithm |
Primary outcome
Percentage of sensor glucose readings within range of 70-180 mg/dl
Time frame: Final visit (day 42)
4 secondary outcomes
Percentage of sensor glucose readings below 54 mg/dl
Time frame: Final visit (day 42)
HbA1c
Time frame: Final visit (day 42)
Number of Severe Hypoglycemia events
Time frame: Final visit (day 42)
Number of Diabetic Ketoacidosis events
Time frame: Final visit (day 42)
Results and safety
The study was stopped early (reason given: Investigators decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
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 MPSA Algorithm in people with Type 1 Diabetes and Multiple Daily Injections, 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 6 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 1 Dec 2020. 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: Investigators 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?
Percentage of sensor glucose readings within range of 70-180 mg/dl (time frame: Final visit (day 42)). 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 1 Dec 2020.