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

NCT ID: NCT06264271

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group with nutrition education

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.

structured nutrition intervention

Intervention Type BEHAVIORAL

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

Group without nutrition education

Patients who received standard care, which may have included short education during routine visits or self-education through online resources or educational materials, were assigned into the group without education.

No interventions assigned to this group

Interventions

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structured nutrition intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Eva Horová, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Horová

Role: PRINCIPAL_INVESTIGATOR

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia

Locations

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Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 12364302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15089791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35441743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32312858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25555391 (View on PubMed)

Navratilova V, Zadakova E, Soupal J, Skrha J Jr, Do QD, Radovnicka L, Haskova A, Prazny M, Horova E. The Effect of Nutrition Education on Glycemic Outcomes in People With Type 1 Diabetes Initiating the Use of Glucose Sensors. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70047. doi: 10.1002/edm2.70047.

Reference Type DERIVED
PMID: 40121673 (View on PubMed)

Other Identifiers

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GIP-22-NL-06-203

Identifier Type: -

Identifier Source: org_study_id

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