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NCT Number: NCT01919385

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

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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

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsum Diabetes Reserach Inst.

Santa Barbara, California, 93105, United States

About this study

This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 21-65 years
  • Type 1 diabetes mellitus for at least one year
  • Currently using an insulin infusion pump for at least the past 6 months

Exclusion criteria

  • Pregnancy
  • History of Diabetic Ketoacidosis (DKA) in the past six months
  • History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months

Treatment and study plan

Predictive Low Glucose Minimizer

Device

This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Other names: type 1 diabetes

Primary outcomes

  1. Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting

    Time frame: 1 week after subject is enrolled in the study

    Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold.

    Ability of the system to issue timely and accurate warnings.

Secondary outcomes

  1. Capturing the number of Adverse Events as a measure of assessing subject safety

    Time frame: 1 week after subject is enrolled in the study

    Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.

Sponsors and collaborators

Lead sponsor

Animas Corporation

Industry

Registry information

Official study title

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2013
Registry last updated
Sep 19, 2013

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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