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MD Logic Pump Advisor- Adults Study

2014-08-27 03:12:24 | BioPortfolio

Summary

Prospective, randomized, controlled, 30 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.Study will consist of 6 clinic visits taking place at intervals of 6 + 3 days, sum of 30-45 days study duration. Main visits will take place at 0,6,12,18,24,30 days and a time window of up to +3 days will be allowed for each visit. During days of study, all subjects will wear 5 iPRO sensors each for 6 days; the intervention group will have 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), the insulin pump setting would not be changed for the control group. For the control group, insulin pump settings will not be changed during the study period (patient's usual standard of care).

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 will consist of 6 clinic visits taking place at intervals of 6 + 3 days, sum of 30-45 days study duration. Main visits will take place at 0,6,12,18,24,30 days and a time window of up to +3 days will be allowed for each visit. During days of study, all subjects will wear 5 iPRO sensors each for 6 days; the intervention group will have 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), the insulin pump setting would not be changed for the control group. For the control group, 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 therapy for at least 3 months

- Age ≥ 18 years

- HbA1c at inclusion ≥ 8.0%

- No concomitant diseases that influence metabolic control

- No current use of CGM

- Subjects do not participate in any other interventional study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 1 Diabetes

Intervention

MD Logic Pump Advisor, No intervention

Location

Schneider Children's Medical center
Petaach-Tikva
Israel
49202

Status

Not yet recruiting

Source

Rabin Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:24-0400

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Medical and Biotech [MESH] Definitions

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

Approximate, quantitative reasoning that is concerned with the linguistic ambiguity which exists in natural or synthetic language. At its core are variables such as good, bad, and young as well as modifiers such as more, less, and very. These ordinary terms represent fuzzy sets in a particular problem. Fuzzy logic plays a key role in many medical expert systems.

A severe type of hyperlipidemia, sometimes familial, that it is characterized by the elevation of both plasma CHYLOMICRONS and TRIGLYCERIDES contained in VERY-LOW-DENSITY LIPOPROTEINS. Type V hyperlipoproteinemia is often associated with DIABETES MELLITUS and is not caused by reduced LIPOPROTEIN LIPASE activity as in HYPERLIPOPROTEINEMIA TYPE I .

Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

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