Accuracy of Lactate Meter in GSDIa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-14

Study Completion Date

2026-03-10

Brief Summary

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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.

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Detailed Description

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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

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Glycogen Storage Disease Type Ia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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