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| Name | Class |
|---|---|
| The Danish Council for Strategic Research | OTHER |
| Medtronic | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| Novo Nordisk A/S |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in this arm continues their usual insulin therapy | |
| Carb counting | Active Comparator | Participants in this arm are taught carb counting |
|
| Carb counting and bolus calculator | Active Comparator | Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Other | Participants are taught the principles of carb counting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in blood glucose | Measured by CGM | 4 months |
| Number of hypoglycemic events | BG < or = 2.8 and/or unconsciousness | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Signe Schmidt, MD | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22344610 | Derived | Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Norgaard K. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care. 2012 May;35(5):984-90. doi: 10.2337/dc11-2044. Epub 2012 Feb 16. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| INDUSTRY |
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| Education |
| Other |
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator. |
|
|
| Treatment satisfaction | Questionnaires | 4 months |
| Total daily insulin dose | 4 months |
| Weight | 4 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |