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
NCT ID: NCT04014569
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2018-05-02
2020-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MPSA Algorithm
Insulin dosing will be adjusted using the MPSA algorithm
MPSA Algorithm
Insulin dosing will be adjusted using the MPSA Algorithm
Interventions
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MPSA Algorithm
Insulin dosing will be adjusted using the MPSA Algorithm
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
14 Years
30 Years
ALL
No
Sponsors
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DreaMed
INDUSTRY
Harvard University
OTHER
Rabin Medical Center
OTHER
Responsible Party
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Locations
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Schnider children medical center
Petah Tikva, , Israel
Countries
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Other Identifiers
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RMC018718ctil
Identifier Type: -
Identifier Source: org_study_id