MD Logic Pump Advisor -Pediatric Study

NCT ID: NCT01308164

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MD Logic Pump Advisor

Intervention Type: DEVICE

Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, Prof

Role: PRINCIPAL_INVESTIGATOR

Schenider Children's Medical

Locations

Schneider Children's Medical center

Petah Tikva, , Israel

University Children's Hospital

Ljubljana, , Slovenia

Countries

Israel; Slovenia

Other Identifiers

rmc005814ctil

Identifier Type: -

Identifier Source: org_study_id