MD Logic Pump Advisor- Adults Study

Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Insulin Pump Therapy
• Intervention / Treatment: Device: MD Logic Pump Advisor

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petaach-Tikva, Israel, 49202
    • Schneider Children's Medical Center
• Slovenia
  • Ljubljana, Slovenia
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in the normal range	increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl	during each 6 days iteration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of iterations required to achieve the maximal meaningful improvement in the primary outcome	number of iterations required to achieve the maximal meaningful improvement in the primary outcome	Day 78
time spent above 180 mg/dl	time spent above 180 mg/dl	during each 6 days iteration
time spent below 70 mg/dl	time spent below 70 mg/dl	during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl	Number of Hypoglycemic events below 63 mg/dl	during each 6 days iteration
Adverse event	Adverse event	during each 6 days iteration
glucose variability- area under the curve	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	during each 6 days iteration
Quality of Life Questionaires	Quality of Life Questionaires	At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician	Number of MDLAP-recommendations that were rejected by the physician	during each 6 days iteration
Number and type of changes in any pump setting per iteration	Number and type of changes in any pump setting per iteration	during each 6 days iteration

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Moshe Phillip, Prof, Schenider Children's Medical

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 27, 2010
• First Submitted That Met QC Criteria: July 4, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Insulin Pump Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: rmc005816ctil