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Completed

NCT Number: NCT01901913

MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management

The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.

The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:

1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop operation with no meal announcement. 2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to test the optimal distribution of insulin delivery during the meal. 3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we will use the results and conclusions from the previous two pilot segments to develop the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this automated insulin bolus calculator will be tested in a randomized cross-over study that will compare postprandial glycemic control under MDLAP with and without the use of the MD-Bolus Calculator.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center

Petah Tikva, Petah-Tikva, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes type 1
  • Age 14-25 years

->1yr since diagnosis

  • Insulin infusion pump therapy for at least 3 months
  • HbA1c at inclusion ≤10%
  • BMI < 95th percentile for age and sex
  • Patients willing to follow study instructions

Exclusion criteria

  • Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
  • any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
  • any concomitant disease that may influence metabolic control
  • participation in any other interventional study
  • known or suspected allergy to trial products
  • any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
  • Female subject who is pregnant or planning to become pregnant within the planned study duration.

Treatment and study plan

MD-bolus calculator for pre-meal bolus

Device

No MD-bolus calculator for pre-meal bolus

Device

Primary outcomes

  1. Area under the curve above 180 mg/dl (10 mmol/l)

    Time frame: 4 hours postprandial

Secondary outcomes

  1. Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal

    Time frame: 4 hours postprandial

  2. The incremental glucose rise from premeal to peak postprandial level

    Time frame: 4 hours postprandial

  3. Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l)

    Time frame: 4 hours postprandial

  4. The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial.

    Time frame: 4 hours postprandial

  5. Percentage of time spent below 70 mg/dl (3.9mmol/l)

    Time frame: 4 hours postprandial

  6. Percentage of time spent above 180, 250, (10, 13.9 mmol/l)

    Time frame: 4 hours postprandial

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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