MD Logic Pump Advisor -Pediatric Study

NCT01308164 | Completed

• 1 other identifier: rmc005814ctil
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 2

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Insulin Pump Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Day 40

Secondary Outcomes (9)

• Number of iterations required to achieve the maximal time spent in the normal range

  day 40

• Time spent above glucose level of 180 mg/dl

  day 40

• Time spent below glucose level of 70 mg/dl

  day 40

• Number of hypoglycemic events below glucose value of 63 mg/dl

  day 40

• Adverse event

  day 40

Study Arms (2)

MD logic Pump Advisor

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

MD Logic Pump Advisor 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

MD logic Pump Advisor

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Medtronic: collaborator

Study Sites (2)

Schneider Children's Medical center

Petah Tikva, 49202, Israel

Location

University Children's Hospital

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Prof

  Schenider Children's Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 3, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

SL (1); IL (1)