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NCT06843330Recruiting

Accuracy of Lactate Meter in GSDIa

Connecticut Children's Medical Center

Start Date

4/14/2025

Completion Date

12/10/2027

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.

Eligibility Criteria

Age Range: No minimum to 60 years

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

Interventions

DEVICE

blood glucose meter; blood lactate meter

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Conditions

Glycogen Storage Disease Type Ia

Locations

Connecticut Children's Medical Center

Hartford, Connecticut 06107

United States