Diabetes Mellitus, Type 1 Clinical Trial
Official title:
The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors
Verified date | February 2024 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 329 |
Est. completion date | February 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age = 18 years - type 1 diabetes duration for at least 12 months prior to sensor initiation - glucose sensor monitoring initiated at the Diabetes Centre of the General University Hospital in Prague Exclusion Criteria: - uncertain diabetes type - pregnancy - change or suspension of glucose sensor monitoring during the study period - unavailability of sensor data - automated insulin delivery treatment |
Country | Name | City | State |
---|---|---|---|
Czechia | Charles University | Prague |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic | General University Hospital, Prague |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | difference in HbA1c | the difference in HbA1c between the groups with and without education | at month 12 | |
Secondary | 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 | |
Secondary | differences in time below range | 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 | |
Secondary | 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 | |
Secondary | differences in coefficient of variation | differences in coefficient of variation between groups with and without education | at month 12 |
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