The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06264271
• Other study ID #: GIP-22-NL-06-203
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• structured nutrition intervention
Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist.

Locations

Country	Name	City	State
Czechia	Charles University	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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

Outcome

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