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MD Logic Pump Advisor -Pediatric Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01308164
First received: February 28, 2011
Last updated: November 6, 2014
Last verified: November 2014

February 28, 2011
November 6, 2014
March 2011
July 2015   (final data collection date for primary outcome measure)
Time spent in the normal range [ Time Frame: Day 40 ] [ Designated as safety issue: No ]
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
Time spent in the normal range [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: No ]
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
Complete list of historical versions of study NCT01308164 on ClinicalTrials.gov Archive Site
  • Number of iterations required to achieve the maximal time spent in the normal range [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    number of iterations required to achieve the maximal time spent in the normal range
  • Time spent above glucose level of 180 mg/dl [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    time spent above glucose level of 180 mg/dl
  • Time spent below glucose level of 70 mg/dl [ Time Frame: day 40 ] [ Designated as safety issue: Yes ]
    time spent below glucose level of 70 mg/dl
  • Number of hypoglycemic events below glucose value of 63 mg/dl [ Time Frame: day 40 ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events below glucose value of 63 mg/dl
  • Adverse event [ Time Frame: day 40 ] [ Designated as safety issue: Yes ]
    adverse event
  • Glucose variability [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    glucose variability
  • Quality of life questionaire [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    quality of life questionaire
  • Number of recommendations the physician would not institute [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    number of MD Logic Pump Advisor recommendations the physician would not institute
  • Number of recommendations for changes in setting per patient and per iPRO wear [ Time Frame: day 40 ] [ Designated as safety issue: No ]
    Number of recommendations for changes in setting per patient and per iPRO wear
  • Number of iterations required to achieve the maximal time spent in the normal range [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: No ]
    number of iterations required to achieve the maximal time spent in the normal range
  • Time spent above glucose level of 180 mg/dl [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: No ]
    time spent above glucose level of 180 mg/dl
  • Time spent below glucose level of 70 mg/dl [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: Yes ]
    time spent below glucose level of 70 mg/dl
  • Number of hypoglycemic events below glucose value of 63 mg/dl [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events below glucose value of 63 mg/dl
  • Adverse event [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: Yes ]
    adverse event
  • Glucose variability [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: No ]
    glucose variability
  • Quality of life questionaire [ Time Frame: at the end of the study period (up to 40 days) ] [ Designated as safety issue: No ]
    quality of life questionaire
  • Number of recommendations the physician would not institute [ Time Frame: at the end of the study - up to 40 days ] [ Designated as safety issue: No ]
    number of MD Logic Pump Advisor recommendations the physician would not institute
  • Number of recommendations for changes in setting per patient and per iPRO wear [ Time Frame: at the end of the study - up to 40 days ] [ Designated as safety issue: No ]
    Number of recomandations for changes in setting per patient and per iPRO wear
Not Provided
Not Provided
 
MD Logic Pump Advisor -Pediatric Study
Evaluation of Automated-Insulin Pump Setting Using the MD-Logic Pump Advisor -Minors Sub Study

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

Study design:

Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.

the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).

The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

Study design:

Prospective study with two segments: (i) Pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT segment, up to 105(50 minors under this protocol and 55 adults under a separate protocol) eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Device: MD Logic Pump Advisor
Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor
  • Experimental: MD logic Pump Advisor
    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
    Intervention: Device: MD Logic Pump Advisor
  • No Intervention: Control Group
    Regular treatment, no change will be made in the insulin pump setting during the study (unless there is a medical need or any safety concern) Only segment 2 of the study, which is conducted as RCT (randomized controlled trial) , will include control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject with Type 1 diabetes (> 1yr since diagnosis)
  • Medetronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII(continuous subcutaneous insulin infusion)therapy for at least 3 months
  • Age 10-18 years old
  • HbA1c at inclusion ≥ 6.0%
  • No concomitant diseases that influence metabolic control
  • No current use of CGM
  • Subjects do not participate in any other interventional study
  • Subject measures SMBG(self-monitoring of blood glucose)at least 4 times a day (before meals and bedtime)

Exclusion Criteria:

  • Known or suspected allergy to trial products
  • Any significant diseases or 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 safety
  • Subject is currently using CGM device
  • Diabetic ketoacidosis in the past 1 month
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
  • Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  • Subject is participating in another drug or device study that could affect glucose measurements or glucose management
  • Female subject who is pregnant or planning to become pregnant within the planned study duration
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Slovenia
 
NCT01308164
rmc005814ctil
No
Rabin Medical Center
Rabin Medical Center
Medtronic
Principal Investigator: Moshe Phillip, Prof Schenider Children's Medical
Rabin Medical Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP