An observational study in Diabetes Mellitus, Type 1, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-06-09.
Sponsored by Boston Children's Hospital · Observational
The investigators have identified a support group on social media with \~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.
The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.
The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 340 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
The social media group on Facebook, TYPEONEGRIT, includes approximately 1500 members, the majority of whom reportedly have type 1 diabetes and follow a carbohydrate-restricted diet.
Exclusion Criteria:
Hemoglobin A1C
self reported, confirmed by professional diabetes care provider if possible
Time frame: within 3 month of taking the survey
total daily insulin dose
self reported, confirmed by professional diabetes care provider if possible
Time frame: within 3 month of taking the survey
total daily dietary carbohydrate
self reported
Time frame: within 3 month of taking the survey
diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
Time frame: timeframe since staring low carb diet (at least three months)
BMI
self reported, confirmed by professional diabetes care provider if possible
Time frame: within 3 month of taking the survey
change in HbA1C
self reported, confirmed by professional diabetes care provider if possible
Time frame: current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
patient-physician relationship
self reported, complemented by professional diabetes care provider if possible
Time frame: within 3 month of taking the survey
Plan to share: Yes — Deidentified data will be shared with external collaborators.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Boston Children's Hospital