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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

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ClinicalTrials.gov Identifier: NCT04014569
Recruitment Status : Terminated (Investigators decision)
First Posted : July 10, 2019
Last Update Posted : December 1, 2020
Sponsor:
Collaborators:
DreaMed
Harvard University
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Multiple Daily Injections Device: MPSA Algorithm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: MPSA Algorithm
Insulin dosing will be adjusted using the MPSA algorithm
Device: MPSA Algorithm
Insulin dosing will be adjusted using the MPSA Algorithm




Primary Outcome Measures :
  1. Percentage of sensor glucose readings within range of 70-180 mg/dl [ Time Frame: Final visit (day 42) ]

Secondary Outcome Measures :
  1. Percentage of sensor glucose readings below 54 mg/dl [ Time Frame: Final visit (day 42) ]
  2. HbA1c [ Time Frame: Final visit (day 42) ]
  3. Number of Severe Hypoglycemia events [ Time Frame: Final visit (day 42) ]
  4. Number of Diabetic Ketoacidosis events [ Time Frame: Final visit (day 42) ]

Other Outcome Measures:
  1. Percentage of sensor glucose readings below 70 mg/dl [ Time Frame: Final visit (day 42) ]
  2. Percentage of sensor glucose readings below 50mg/dl [ Time Frame: Final visit (day 42) ]
  3. Percentage of sensor glucose readings above 180mg/dl [ Time Frame: Final visit (day 42) ]
  4. Percentage of sensor glucose readings above 250mg/dl [ Time Frame: Final visit (day 42) ]
  5. Number of unexplained hyperglycemic events [ Time Frame: Final visit (day42) ]
  6. Area above the curve of 180mg/dl [ Time Frame: Final visit (day 42) ]
  7. Area above the curve >180mg/dl [ Time Frame: Final visit (day 42) ]
  8. Area under the curve of 70mg/dl [ Time Frame: Final visit (day 42) ]
  9. Area under the curve <70mg/dl [ Time Frame: Final visit (day 42) ]
  10. Mean sensor blood glucose [ Time Frame: Final visit (day42) ]
  11. Glucose variability measured by SD (standard deviation) [ Time Frame: Final visit (day 42) ]
  12. Number of recommendations for changes in settings per patient [ Time Frame: Final visit (day 42) ]
  13. Number of recommendations for changes in setting per iteration [ Time Frame: Final visit (day 42) ]
  14. Number of physician override advisor recommendations [ Time Frame: Final visit (day 42) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014569


Locations
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Israel
Schnider children medical center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
DreaMed
Harvard University
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04014569    
Other Study ID Numbers: RMC018718ctil
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases