Evaluating the accuracy of home lactate meters in patients with Glycogen Storage Disease Type Ia
Official title: Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
Run by Connecticut Children's Medical Center · NCT06843330 · Data updated 2026-11-12
This study tests if home lactate meters give accurate readings for people with Glycogen Storage Disease Type Ia by comparing them to lab results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | March 10, 2027 |
| Study ends | December 10, 2027 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT06843330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with Glycogen Storage Disease Type Ia who are receiving care at Connecticut Children's Medical Center.
✕Probably not a fit
Patients with unspecified Glycogen Storage Disease or those with Glycogen Storage Disease Type Ib will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the accuracy of home lactate meters, both capillary and serum samples, in patients diagnosed with Glycogen Storage Disease Type Ia. It will compare the readings from these home devices to lab serum lactate measurements to determine if they are within 20% accuracy 95% of the time. Additionally, the study will evaluate the accuracy of the Accu Chek Guide glucometer for capillary blood glucose readings against lab serum glucose levels in the same patient population.
Why it matters
Potential benefit: If successful, this study could enable patients to monitor their lactate and glucose levels more accurately at home, improving disease management.
How similar studies have gone: While there have been studies on lactate meter accuracy in other conditions, this specific approach in Glycogen Storage Disease Type Ia is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Connecticut Children's Medical Center
Hartford, Connecticut, United States Recruiting
Study contacts
- Study coordinator: Malaya Mount, MS, RD
- Email: mmount@connecticutchildrens.org
- Phone: 860-837-6700
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Home lactate and Accu‑Chek glucose meter accuracy for people with glycogen storage disease
This project will see if a handheld Lactate Plus meter and an Accu‑Chek glucometer give results that match lab blood tests in people with glycogen storage disease types Ia, Ib, and XI.
-
Evaluating BEAM-301 for treating Glycogen Storage Disease Type Ia
This study is testing a new treatment called BEAM-301 to see if it is safe and effective for adults with Glycogen Storage Disease Type Ia who have a specific genetic variant.
-
Monitoring program for patients with Glycogen Storage Disease Type Ia
This study is tracking the long-term health and safety of a treatment called DTX401 in people with Glycogen Storage Disease Type Ia to see how it helps them over at least 10 years.
-
Glycogen Storage Disease and Brain Function in People Like You
This study tests whether people with glycogen storage disease perform differently on cognitive tests and show different brain imaging features compared with healthy peers.
-
Using advanced heart MRI to improve diagnosis and risk prediction for rare cardiomyopathies
This project tests whether advanced cardiac MRI techniques can help diagnose and predict future risk for people with rare heart muscle diseases like Danon, Fabry, cardiac amyloidosis, Noonan syndrome, and cardiac sarcoidosis.
-
Identifying patients with cardiomyopathy for potential heart transplantation
This study is trying to find new ways to identify and understand cardiomyopathy in patients to better predict if they might need a heart transplant in the future.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.