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Prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients
Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee (C-558).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Flash adherence | Experimental | Adult (>18 yrs old) type 1 diabetes patients with 4 or less daily Flash scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes educational program | Other | 30-minute long diabetes educational program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Flash 1 | Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose | 14 days |
| Adherence to Flash 2 | Time of use of intermittently scanned continuous glucose monitoring (% possible time of use) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Moreno-Fernandez, PhD | Ciudad Real General University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciudad Real General University Hospital | Ciudad Real | 13005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28970034 | Result | Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018 Feb;6(2):130-142. doi: 10.1016/S2213-8587(17)30239-5. Epub 2017 Sep 29. | |
| 30844467 | Result | Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4. |
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Under other researchers request.
Data will become available after 1 month of the request and for a 3-month period.
After request study from IP and ethic comittee.
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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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30 minutes diabetes educational program:
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| 14 days |
| Time below range 1 (TBR1) | Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose | 14 days |
| Time below range 2 (TBR2) | Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose | 14 days |
| Time above range 1 (TAR1) | Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose | 14 days |
| Time above range 2 (TAR2) | Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose | 14 days |
| Coefficient of variation percentage (CV) | Coefficient of variation percentage of interstitial glucose | 14 days |
| Glucose management index | Glucose management index of interstitial glucose | 14 days |
| Time in hypoglycemia | Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose | 14 days |
| Hypoglycemia frequency | Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose | 14 days |
| Percentage of patients attaining the the International Consensus on Time in Range (ICTR) | Percentage of patients (from total) attaining TIR>70%, TBR1<4%, TBR2<1%, TAR1<25%, TAR2<5% and CV <36% | 14 days |
| 27634581 | Result | Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12. |
| 29278709 | Result | Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24. |
| 32198165 | Result | Gomez-Peralta F, Dunn T, Landuyt K, Xu Y, Merino-Torres JF. Flash glucose monitoring reduces glycemic variability and hypoglycemia: real-world data from Spain. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001052. doi: 10.1136/bmjdrc-2019-001052. |
| 41968908 | Derived | Pazos-Couselo M, Izquierdo V, Martinez MM, Romero FJG, Munoz-Rodriguez JR, Fernandez-Pombo A, Moreno-Fernandez J. A Nurse-Led Educational Intervention for Patients With Type 1 Diabetes Using Continuous Glucose Monitoring. Worldviews Evid Based Nurs. 2026 Apr;23(2):e70139. doi: 10.1111/wvn.70139. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |