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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: structured nutrition intervention

• Registration Number: NCT06264271
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Study Completion: 2024-02-01
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-16
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with nutrition education	structured nutrition intervention	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.

Primary Outcome Measures

Name	Time	Method
difference in HbA1c	at month 12	the difference in HbA1c between the groups with and without education

Secondary Outcome Measures

Name	Time	Method
differences in time in range	at month 12	differences in time in range (percentages) (70-180 mg/dL \[3.9-10.0 mmol/L\]) between groups with and without education
differences in time below range	at month 12	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
differences in time above range	at month 12	differences in time above range (percentages) (\>181 mg/dL \[\>10.1 mmol/L\]) between groups with and without education
differences in coefficient of variation	at month 12	differences in coefficient of variation between groups with and without education

Trial Locations

Locations (1)

Charles University; 🇨🇿 Prague, Czechia