NCT06843330

Accuracy of Lactate Meter in GSDIa

Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: All
• Age: 0 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

Detailed description

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

Conditions

• Glycogen Storage Disease Type Ia

Interventions

Type	Name	Description
DEVICE	blood glucose meter; blood lactate meter	Blood lactate level measured by finger-stick with over the counter meter. Blood glucose level measured by finger-stick.

Timeline

• Start date: 2025-04-14
• Primary completion: 2027-03-10
• Completion: 2027-12-10
• First posted: 2025-02-24
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study