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

Animas

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Hypo-Hyper Minimizer (HHM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638299

3076823, V3.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Hypo-Hyper Minimizer (HHM) System

Experimental group

Treatment:

Device: Hypo-Hyper Minimizer (HHM) System