Evaluating the accuracy of home lactate meters in patients with Glycogen Storage Disease Type Ia
Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
Connecticut Children's Medical Center · NCT06843330
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 0 Years to 60 Years |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center (other) |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT06843330 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unspecified Glycogen Storage Disease or those with Glycogen Storage Disease Type Ib will not benefit from this study.
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 performed: While there have been studies on lactate meter accuracy in other conditions, this specific approach in Glycogen Storage Disease Type Ia is novel.
Eligibility criteria
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 this trial is running
Hartford, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glycogen Storage Disease Type Ia, Glycogen Storage Disease type Ia, Blood lactate, Glycogen Storage Disease Ia blood glucose, GSD I, GSDIa, Blood glucose, Accu chek glucometer