NCT01401751

Brief Summary

The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

July 21, 2011

Last Update Submit

January 31, 2025

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusArtificial Pancreas

Outcome Measures

Primary Outcomes (1)

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

    Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.

    End of Study - in approximately 5 months from first subject enrolled

Secondary Outcomes (1)

  • Safety Evaluation

    End of Study - in approximately 5 months from first subject enrolled

Study Arms (1)

Single Arm

OTHER

non-randomized, uncontrolled, feasibility study

Device: Hypoglycemia-Hyperglycemia Minimizer System

Interventions

Hypoglycemia-Hyperglycemia Minimizer SystemDEVICE

Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm

Single Arm

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Age 21-65 years
  • Type 1 diabetes mellitus for at least one year
  • Using an insulin infusion pump for at least the past 6 months
  • Pregnancy
  • History of diabetic ketoacidosis (DKA) in the past six months
  • History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
  • Please contact clinical study site for complete details.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Howard Zisser, MD

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

US(1)