MD Logic Pump Advisor- Adults Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01157923
First received: June 27, 2010
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.

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.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).


Condition Intervention
Type 1 Diabetes
Insulin Pump Therapy
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 Settings Using the MD-Logic Pump Advisor-Adults 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: during each 6 days iteration ] [ 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 meaningful improvement in the primary outcome [ Time Frame: Day 78 ] [ Designated as safety issue: No ]
    number of iterations required to achieve the maximal meaningful improvement in the primary outcome

  • time spent above 180 mg/dl [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: No ]
    time spent above 180 mg/dl

  • time spent below 70 mg/dl [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: Yes ]
    time spent below 70 mg/dl

  • Number of Hypoglycemic events below 63 mg/dl [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: Yes ]
    Number of Hypoglycemic events below 63 mg/dl

  • Adverse event [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: Yes ]
    Adverse event

  • glucose variability- area under the curve [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: No ]
    glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl

  • Quality of Life Questionaires [ Time Frame: At the end of the study- day 30 -78 ] [ Designated as safety issue: No ]
    Quality of Life Questionaires

  • Number of MDLAP-recommendations that were rejected by the physician [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: No ]
    Number of MDLAP-recommendations that were rejected by the physician

  • Number and type of changes in any pump setting per iteration [ Time Frame: during each 6 days iteration ] [ Designated as safety issue: No ]
    Number and type of changes in any pump setting per iteration


Estimated Enrollment: 135
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervantion group
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.
Device: MD Logic Pump Advisor
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration 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).

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.

The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Endpoints:

  • Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
  • Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.

Inclusion Criteria:

  • Subject with Type 1 diabetes (>1yr since diagnosis)
  • Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
  • Age ≥ 18 years
  • 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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject with Type 1 diabetes (>1yr since diagnosis)
  2. Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
  3. Age ≥ 18 years
  4. HbA1c at inclusion ≥ 6.0%
  5. No concomitant diseases that influence metabolic control
  6. No current use of CGM
  7. Subjects do not participate in any other interventional study

Exclusion Criteria:

  1. Known or suspected allergy to trial products.
  2. 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
  3. Subject is currently using CGM device
  4. Diabetic ketoacidosis in the past 3 months.
  5. Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
  6. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  7. Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
  8. 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: NCT01157923

Locations
Israel
Schneider Children's Medical center
Petaach-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: NCT01157923     History of Changes
Other Study ID Numbers: rmc005816ctil
Study First Received: June 27, 2010
Last Updated: September 12, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
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 September 18, 2014