Type 1 diabetes mellitus (DM1) Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus (DM1)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 1 diabetes mellitus 2. Aged between 18 and 50 years 3. Regular follow-up with an Endocrinologist 4. HbA1c =7% 5. Treatment with basal-bolus insulin (multiple daily injections) at a stable dose for at least 3 months prior visit 1 (variation of up to 10% of dose was permitted)
Exclusion criteria
Exclusion criteria: 1. Previous and concomitant history of metabolic bone diseases, liver disease, abnormal glomerular filtration rate (GFR) levels 2. Patients that made use of vitamin D or calcium within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic variability is assessed using continuous glucose monitoring from baseline to three months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vitamin D (25(OH)D) levels are measured by immonoassay on blood samples collected at baseline and three months 2. Albuminuria levels are measured by immunoturbidimetry at baseline and three months 3. Autonomic cardiovascular neuropathy is measured by physical examination and ECG at baseline and three months | — |
Countries
Brazil