Accuracy of Lactate Meter in GSDIa

Recruiting

• Conditions: Glycogen Storage Disease Type Ia

• Registration Number: NCT06843330
• Lead Sponsor: Connecticut Children's Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-24
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-03-10
• Study Completion: 2026-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
• Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
• For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
• For adults: Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Patients with Glycogen storage disease unspecified 74.00, or Ib
• Patients not meeting inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Home lactate meter accuracy in GSDIa compared with lab lactate	Every 1-3 hours for a maximum 33 hours	Lactate level via point of care finger-stick and lab draw

Secondary Outcome Measures

Name	Time	Method
Glucometer accuracy in GSDIa compared with lab lactate	Every 1-3 hours for a maximum 33 hours	Glucose level via finger-stick and lab draw

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States