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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
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The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education.
Education on carbohydrate counting and flexible insulin dosing improves glycemic control, which is also enhanced by glucose sensor usage. However, the combined effect of structured education and the initiation of sensor monitoring remains unclear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with nutrition education | Patients who experienced at least one structured education session between 24 months before sensor initiation and 6 months after sensor initiation were allocated to the group with education. |
| |
| Group without nutrition education | Patients who received standard care, which may have included short education during routine visits or self-education through online resources or educational materials, were assigned into the group without education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured nutrition intervention | Behavioral | Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in HbA1c | the difference in HbA1c between the groups with and without education | at month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| differences in time in range | differences in time in range (percentages) (70-180 mg/dL [3.9-10.0 mmol/L]) between groups with and without education | at month 12 |
| differences in time below range |
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Inclusion Criteria:
Exclusion Criteria:
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Patients age ≥ 18 years, T1D duration for at least 12 months prior to sensor initiation, and all sensor monitoring initiated at the Diabetes Centre of the General University Hospital in Prague.
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| Name | Affiliation | Role |
|---|---|---|
| Eva Horová | 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles University | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12364302 | Background | DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ. 2002 Oct 5;325(7367):746. doi: 10.1136/bmj.325.7367.746. | |
| 15089791 | Background | Shearer A, Bagust A, Sanderson D, Heller S, Roberts S. Cost-effectiveness of flexible intensive insulin management to enable dietary freedom in people with Type 1 diabetes in the UK. Diabet Med. 2004 May;21(5):460-7. doi: 10.1111/j.1464-5491.2004.01183.x. |
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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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differences in time below range (percentages) in level 1 hypoglycemia (54-69 mg/dL [3.0-3.8 mmol/L]), level 2 hypoglycemia (<54 mg/dL [<3.0 mmol/L]) between groups with and without education
| at month 12 |
| differences in time above range | differences in time above range (percentages) (>181 mg/dL [>10.1 mmol/L]) between groups with and without education | at month 12 |
| differences in coefficient of variation | differences in coefficient of variation between groups with and without education | at month 12 |
| 35441743 | Background | Elbalshy M, Haszard J, Smith H, Kuroko S, Galland B, Oliver N, Shah V, de Bock MI, Wheeler BJ. Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials. Diabet Med. 2022 Aug;39(8):e14854. doi: 10.1111/dme.14854. Epub 2022 Apr 25. |
| 32312858 | Background | Maiorino MI, Signoriello S, Maio A, Chiodini P, Bellastella G, Scappaticcio L, Longo M, Giugliano D, Esposito K. Effects of Continuous Glucose Monitoring on Metrics of Glycemic Control in Diabetes: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Diabetes Care. 2020 May;43(5):1146-1156. doi: 10.2337/dc19-1459. |
| 25555391 | Background | Vigersky RA. The benefits, limitations, and cost-effectiveness of advanced technologies in the management of patients with diabetes mellitus. J Diabetes Sci Technol. 2015 Mar;9(2):320-30. doi: 10.1177/1932296814565661. |
| 40121673 | Derived | Navratilova V, Zadakova E, Soupal J, Skrha J Jr, Do QD, Radovnicka L, Haskova A, Prazny M, Horova E. The Effect of Nutrition Education on Glycemic Outcomes in People With Type 1 Diabetes Initiating the Use of Glucose Sensors. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70047. doi: 10.1002/edm2.70047. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |