New eDiary helps track sickle cell pain and fatigue
NCT ID NCT05407805
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an electronic diary for adults with sickle cell disease to track daily symptoms like pain, tiredness, and ability to do usual activities. About 98 participants used the diary for 6 months, and researchers compared those on disease-modifying treatment to those not on any. The goal was to see how well the diary captures real-world experiences of sickle cell crises.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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98 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants with a confirmed diagnosis of stable Sickle Cell Disease (SCD) (hemoglobin S inherited from both parents \[HbS/S\] or hemoglobin S inherited from one parent and hemoglobin beta thalassemia inherited from the other parent \[HbS/beta-zero-thalassemia\] genotype) who are either not on disease modifying treatment or on a stable dose of a SCD disease modifying treatment regimen.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (All Groups): \- Confirmed diagnosis of stable SCD (HbS/S or HbS/beta-zero-thalassemia). Additional Inclusion Criteria (No Disease Modifying Treatment Control Group): * Have experienced ≥1 episode(s) of medical utilization (MU) VOC within 12 months prior to Screening. * Data available for number of MU VOC(s) during the 12-month interval prior to Screening and a value for %fetal hemoglobin (HbF) collected subsequent to 1 year of age in the absence of recent transfusion. Additional Inclusion Criteria (SCD Disease Modifying Treatment Group): * Have experienced ≥1 episode(s) of MU VOC within 12 months prior to initiation of HU and/or crizanlizumab (whichever was initiated earlier). * Must be on a stable dose of their SCD treatment regimen ≥8 weeks prior to Day 1 with the intent of remaining on the same dose throughout the study, unless adjustments are medically necessary due to bone marrow suppression, in accordance with published guidelines and/or product specific guidance (eg, package label). Accepted SCD disease modifying treatment regimens include: * HU alone and/or in combination with crizanlizumab, L-glutamine and/or voxelotor; or * Crizanlizumab alone and/or in combination with HU, L-glutamine and/or voxelotor. * Data available for number of MU VOC(s) during the 12-month interval prior to initiation of any SCD disease modifying treatment, as described above, and a value for %HbF collected subsequent to 1 year of age, prior to initiation of any HU treatment, and in the absence of recent transfusion. Exclusion Criteria (All Groups): * Evidence or history of ongoing (condition or sequelae) clinically significant hematological (non-SCD), renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including overt stroke but excluding silent cerebral infarct), hepatic (excluding cholelithiasis), psychiatric or neurological disease as assessed from medical records. * Marked ongoing bone marrow suppression as evidenced by any of the following as per medical record: severe anemia, absolute neutrophil count (ANC) \<1000 mm3 white blood cell (WBC), thrombocytopenia (platelet count \<100,000 mm3) within ≤8 weeks prior to Day 1 enrollment. * History of hematopoietic stem cell transplant or treatment with gene therapy as assessed from medical records. * History of simple transfusion within ≤4 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report. * History of chronic transfusion/exchange transfusion within ≤12 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report and/or plan to initiate such treatment during the 6-month observation period. Additional Exclusion Criteria (No Disease Modifying Treatment Control Group): * Participant received HU and/or crizanlizumab at any time within ≤18 months of Day 1 enrollment and treatment(s) was discontinued due to lack of efficacy (no reduction in the frequency of VOCs, documented or perceived) and/or plan to initiate said treatment(s) during the 6-month observation period. * Participant received voxelotor or L-glutamine within ≤4 weeks of Day 1 enrollment and/or plan to initiate said treatment(s) during the 6-month observation period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cohen Children's Medical Center
New Hyde Park, New York, 11040, United States
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Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33024, United States
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Mid-Atlantic Permanente Medical Group Largo Medical Center
Upper Marlboro, Maryland, 20774, United States
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Sanguine Biosciences, Inc.
Waltham, Massachusetts, 02451, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
- Tiny biochip could reveal sickle cell severity
- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?
- Can a softer transplant cure sickle cell disease?