Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes

NCT01501032 | Withdrawn Phase 1

• 1 other identifier: rmc006385ctil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.

Conditions

Diabetes Type 1

Keywords

Diabetes Type 1; Artificial Pancreas

Outcome Measures

Primary Outcomes (7)

• Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit

  Day 1

• Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus

  Success is defined as \>=40% subjects with a blood glucose in the 71-180 mg/dL range.

  Day 1

• Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount

  Success is defined as \>=50% subjects with a blood glucose in the 71-180 mg/dL range.

  Day 2

• Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise

  Success is defined as less than 25% of subjects with a blood glucose nadir \<=60 mg/dL.

  Day 3

• Overall frequency of hypoglycemia

  Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.

  day 3

• Overall frequency of hyperglycemia

  Success defined as no subjects with diabetic ketoacidosis (DKA).

  Day 3

• Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount

  Success is defined as less than 5% of subjects have a peak blood glucose \>400 mg/dL

  day 2

Secondary Outcomes (7)

• Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit

  Day 1

• Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit

  Day 1

• Percent of blood glucose values >400 mg/dL during the first admission visit

  Day 1

• Percent of blood glucose values <=60 mg/dL during the first admission visit

  Day 1

• Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus

  Day 1

Study Arms (1)

Closed Loop Control- MD-Logic

EXPERIMENTAL

The MD-Logic artificial pancreas system will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.

Device: MD-logic artificial pancreas system

Interventions

MD-logic artificial pancreas system DEVICE

The MD-logic artificial pancreas system is a closed loop control system using continuous glucose monitoring (CGM)and subcutaneous insulin pump infusion to mange glucose control in individuals with type 1 diabetes

Closed Loop Control- MD-Logic

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
• Age 12 to 65 years
• Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
• For females, not currently known to be pregnant
• Demonstration of proper mental status and cognition for the study
• An understanding of and willingness to follow the protocol and sign the informed consent or assent

You may not qualify if:

• Diabetic ketoacidosis in the past 6 months
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• History of a seizure disorder (except hypoglycemic seizure).
• Coronary artery disease or heart failure.
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
• Current use of a beta blocker medication
• Hematocrit \<30%
• Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider children's Medical center

Petah Tikva, 49202, Israel

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

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 29, 2011
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

IL (1)