Accuracy of Lactate Meter in GSDIa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood glucose meter; blood lactate meter.
- Who it may be relevant to
- Registry conditions: Glycogen Storage Disease Type Ia. Basic parameters: 0 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
Overview
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.
Interventions
- 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.
Primary outcome measures
- Home lactate meter accuracy in GSDIa compared with lab lactate [Time frame: Every 1-3 hours for a maximum 33 hours]
Secondary outcome measures (1)
- Glucometer accuracy in GSDIa compared with lab lactate [Time frame: Every 1-3 hours for a maximum 33 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Connecticut Children's Medical Center — Hartford
Identifiers
NCT: NCT06843330 · 23-137