Actively Recruiting
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Led by Connecticut Children's Medical Center · Updated on 2026-06-01
10
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Connecticut Children's Medical Center
Lead Sponsor
G
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the accuracy of two home monitoring devices—the Lactate Plus meter and the Accu-Chek Guide glucometer—in patients with Glycogen Storage Disease Types Ia, Ib, and XI. The study focuses on comparing these devices' readings with laboratory serum lactate and glucose levels to determine their reliability for this patient group. Participants will have a one-time planned hospital admission lasting about 8 hours, during which they will undergo hourly blood draws and finger-stick tests. These measurements will be used to compare the device readings against lab results throughout the 8-hour period. During the study visit, patients will have blood samples taken every hour alongside finger-stick glucose checks. Researchers will assess whether the Lactate Plus meter and Accu-Chek glucometer readings are within 20% of the laboratory values 95% of the time. This careful monitoring and comparison will help determine the accuracy of these home testing devices for managing Glycogen Storage Disease.
CONDITIONS
Brief Title
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Glycogen Storage Disease Type Ia, Ib, or XI confirmed by liver biopsy or genetic testing
- For pediatric participants: parent or legal guardian able to understand and sign informed consent
- Adolescents able to provide assent to participate
- Adults able to understand and willing to sign informed consent
You will not qualify if you...
- Patients with unspecified Glycogen Storage Disease
- Patients not meeting the inclusion criteria
- Patients unable to provide consent
- Patients who decline to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 hours
Participants have their blood lactate and glucose levels measured hourly for 8 hours using home devices and lab tests.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Connecticut Children's
Hartford, Connecticut, United States, 06106
Actively Recruiting
Research Team
M
Malaya Mount, MS, RD, CDN
M
Malaya Mount
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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