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

Type 1 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638299
• Other study ID #: 3076823, V3.0
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2012
• Last updated: September 19, 2012
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Animas Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Hypo-Hyper Minimizer (HHM) System
Adjustment of Insulin dosing during meal time

Locations

Country	Name	City	State
United States	UVA Diabetes Technology Center	Charlottesville	Virginia
United States	Samsum Diabetes Reserach Inst.	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Animas Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes