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

NCT06264271 | Completed

• 1 other identifier: GIP-22-NL-06-203
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• difference in HbA1c

  the difference in HbA1c between the groups with and without education

  at month 12

Secondary Outcomes (4)

• differences in time in range

  at month 12

• differences in time below range

  at month 12

• differences in time above range

  at month 12

• differences in coefficient of variation

  at month 12

Study Arms (2)

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.

Behavioral: structured nutrition intervention

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.

Interventions

structured nutrition intervention BEHAVIORAL

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

Group with nutrition education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• uncertain diabetes type
• pregnancy
• change or suspension of glucose sensor monitoring during the study period
• unavailability of sensor data
• automated insulin delivery treatment

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

Charles University

Prague, 12808, Czechia

Location

Related Publications (6)

• 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.

  PMID: 12364302 BACKGROUND

• 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.

  PMID: 15089791 BACKGROUND

• 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.

  PMID: 35441743 BACKGROUND

• 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.

  PMID: 32312858 BACKGROUND

• 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.

  PMID: 25555391 BACKGROUND

• 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.

  PMID: 40121673 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eva Horová

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 16, 2024
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)