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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
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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 Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACC | Active Comparator | Training in advanced carbohydrate counting |
|
| ACC + ABC | Experimental | Training in advanced carbohydrate counting plus the use of an automated bolus calculator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated bolus calculator | Device | Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of serious hypoglycemic events | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study | Baseline, 12 months | |
| Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva E Hommel, MD, DMSc | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22344610 | Background | 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. | |
| 27761942 | Derived |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Advanced Carbohydrate Counting | Behavioral | Training in advanced carbohydrate counting. |
|
| Baseline, 12 months |
| Treatment Satisfaction | Measured by Diabetes Treatment Satisfaction Questionnaire | Baseline, 12 months |
| Hommel E, Schmidt S, Vistisen D, Neergaard K, Gribhild M, Almdal T, Norgaard K. Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial. Diabet Med. 2017 May;34(5):708-715. doi: 10.1111/dme.13275. Epub 2016 Nov 10. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |