NCT01638299

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 21, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

June 25, 2012

Last Update Submit

September 19, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusArtificial Pancreas

Outcome Measures

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.

    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

    After subject is discharged from CRC, 1 week after enrolment

Study Arms (1)

Hypo-Hyper Minimizer (HHM) System

EXPERIMENTAL
Device: Hypo-Hyper Minimizer (HHM) System

Interventions

Hypo-Hyper Minimizer (HHM) SystemDEVICE

Adjustment of Insulin dosing during meal time

Also known as: Insulin delivery
Hypo-Hyper Minimizer (HHM) System

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsum Diabetes Reserach Inst.

Santa Barbara, California, 93105, United States

Location

UVA Diabetes Technology Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Henry Anhalt, DO

    Animas Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 21, 2012

Record last verified: 2012-09

Locations

US(2)