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: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: MD Logic Pump Advisor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Automated-Insulin Pump Setting Using the MD-Logic Pump Advisor -Minors Sub Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308164

Locations
Israel
Schneider Children's Medical center
Petach-Tikva, Israel, 49202
Slovenia
University Children's Hospital
Ljubljana, Slovenia
Sponsors and Collaborators
Rabin Medical Center
Medtronic
Investigators
Principal Investigator: Moshe Phillip, Prof Schenider Children's Medical
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01308164     History of Changes
Other Study ID Numbers: rmc005814ctil
Study First Received: February 28, 2011
Last Updated: September 12, 2013
Health Authority: Israel:Clalit Health Services

Keywords provided by Rabin Medical Center:
Type 1 diabetes
Insulin Pump Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014