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

The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06264271
Enrollment
329
Registered
2024-02-16
Start date
2022-02-01
Completion date
2024-02-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

carbohydrate counting, flexible insulin dosing, structured education, glycemic control, glucose monitoring

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.

Interventions

BEHAVIORALstructured nutrition intervention

Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist.

Sponsors

General University Hospital, Prague
CollaboratorOTHER
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
difference in HbA1cat month 12the difference in HbA1c between the groups with and without education

Secondary

MeasureTime frameDescription
differences in time in rangeat month 12differences 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 rangeat month 12differences 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 rangeat month 12differences in time above range (percentages) (\>181 mg/dL \[\>10.1 mmol/L\]) between groups with and without education
differences in coefficient of variationat month 12differences in coefficient of variation between groups with and without education

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026