Type 1 Diabetes
Conditions
Keywords
Carbohydrate counting, Insulin bolus calculation
Brief summary
The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.
Interventions
OTHEREducation
Participants are taught the principles of carb counting
Sponsors
The Danish Council for Strategic Research
Medtronic
Roche Pharma AG
Novo Nordisk A/S
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Diabetes duration at least 12 months * MDI therapy * HbA1c 8-10,5% (both included)
Exclusion criteria
* Gastroparesis * Present or former practice of carbohydrate counting * Pregnancy or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in blood glucose | 4 months | Measured by CGM |
| Number of hypoglycemic events | 4 months | BG \< or = 2.8 and/or unconsciousness |
| Treatment satisfaction | 4 months | Questionnaires |
| Total daily insulin dose | 4 months | — |
| Weight | 4 months | — |
Countries
Denmark
Outcome results
None listed