Accuracy of Lactate Meter in GSDIa
ConditionGlycogen Storage Disease Type Ia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-60
SponsorConnecticut Children's Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with Glycogen storage disease unspecified 74.00, or Ib
Patients not meeting inclusion criteria
Trial population
Patients of Connecticut Children's birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia, that are seen in clinic between 7/2020 - 7/2024, or that present to emergency room or are admitted to Connecticut Children's for surgery, acute illness or dose titration admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood glucose meter; blood lactate meter
DeviceBlood lactate level measured by finger-stick with over the counter meter. Blood glucose level measured by finger-stick.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Home lactate meter accuracy in GSDIa compared with lab lactate
Lactate level via point of care finger-stick and lab draw
Time frame
Every 1-3 hours for a maximum 33 hoursSecondary outcomes
1
Glucometer accuracy in GSDIa compared with lab lactate
Glucose level via finger-stick and lab draw
Time frame
Every 1-3 hours for a maximum 33 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Connecticut Children's Medical Center
Lead sponsor
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Collaborator
Source ClinicalTrials.gov