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OpenTrials
Completed

NCT Number: NCT01781533

Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor

To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged 18 to 75 years (both inclusive)
  • Informed consent obtained after being advised of the nature of the study
  • The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
  • The subject's HbA1c <= 10%
  • Body Mass Index (BMI) <= 35 kg/m2
  • The subject is treated with continuous subcutaneous insulin infusion for at least 3 month

Exclusion criteria

  • Subject is actively enrolled in another clinical trial or took part in a study within 30 days
  • Experienced recurrent severe hypoglycaemic unawareness
  • Total daily insulin dose >= 1.4 IU/kg
  • Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
  • Allergy against insulin Lispro
  • A history of drug or alcohol dependence
  • Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
  • Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  • Patient is pregnant, or breast feeding during the period of the study
  • Patient donated blood in the last 3 months

Treatment and study plan

algorithm

Procedure

Primary outcomes

  1. the percentage of glucose values obtained every 15 min in predefined glucose ranges

    Time frame: 15 minutes

Secondary outcomes

  1. Injected insulin dose

    Time frame: 24 hours

  2. Accuracy of the glucose monitoring unit

    Time frame: 24 hours

    The absolute and relative difference between glucose monitoring readings and reference values (blood glucose) will be used to determine the accuracy of the monitoring unit

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2013
Registry last updated
Mar 18, 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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