Clinical trial NCT06264271: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes
Official title: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: carbohydrate counting
flexible insulin dosing
structured education
glycemic control
glucose monitoring
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
First posted: 2024-02-16
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: difference in HbA1c
timeFrame: at month 12
Secondary outcomes:
measure: differences in time in range
timeFrame: at month 12
measure: differences in time below range
timeFrame: at month 12
measure: differences in time above range
timeFrame: at month 12
measure: differences in coefficient of variation
timeFrame: at month 12
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Charles University
Study officials:
affiliation: 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia
name: Eva Horová
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.