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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01638299

Enrollment

Registered

2012-07-11

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2012-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, Artificial Pancreas

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.

Detailed 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.

Interventions

DEVICEHypo-Hyper Minimizer (HHM) System

Adjustment of Insulin dosing during meal time

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026