Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carb counting and bolus calculator | Active Comparator | Education in carb counting and the use of an automated bolus calculator |
|
| Carb counting | Placebo Comparator | Education in carb counting and manual calculation of insulin bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated bolus calculator | Device |
| ||
| Education |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM) | 6 months | |
| Frequency of blood glucose measurements assessed by meter download before randomization and at each visit | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherences to bolus calculator use | Using questionnaire | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32846108 | Derived | Christensen MB, Serifovski N, Herz AMH, Schmidt S, Hommel E, Raimond L, Perrild H, Gotfredsen A, Gaede P, Norgaard K. Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial. Diabetes Technol Ther. 2021 Feb;23(2):95-103. doi: 10.1089/dia.2020.0276. Epub 2020 Sep 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance) | 6 months |
| Change in diet habits/diet composition | Assessed by electronic diet recordings | 6 months |
| Change in treatment satisfaction | Using questionnaire | 6 months |
| D004700 | Endocrine System Diseases |