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NCT Number: NCT01638299

Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting

Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research setting.

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Key information

Conditions

Type 1 Diabetes Mellitus 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, United States

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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
  • Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months

Treatment and study plan

Hypo-Hyper Minimizer (HHM) System

Device

Adjustment of Insulin dosing during meal time

Other names: Insulin delivery

Primary outcomes

  1. Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.

    Time frame: After subject is discharged from CRC, 1 week after enrolment

Secondary outcomes

  1. Number of Safety Events and any additional information that can be used for product development

    Time frame: After subject is discharged from CRC, 1 week after enrolment

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 and Hyperglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2012
Registry last updated
Sep 21, 2012

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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