Diabetes Mellitus, Type 1NCT06264271
The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- structured nutrition intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 329 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- uncertain diabetes type
- pregnancy
- change or suspension of glucose sensor monitoring during the study period
- unavailability of sensor data
- automated insulin delivery treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- structured nutrition intervention
- Keywords
- carbohydrate counting, flexible insulin dosing, structured education, glycemic control, glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured nutrition interventionBehavioural
Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in HbA1c
the difference in HbA1c between the groups with and without education
Measured: at month 12
Secondary outcomes (4)
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
Measured: at month 12
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
Measured: at month 12
differences in time above range
differences in time above range (percentages) (>181 mg/dL [>10.1 mmol/L]) between groups with and without education
Measured: at month 12
differences in coefficient of variation
differences in coefficient of variation between groups with and without education
Measured: at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Feb 2022
- Primary completion31 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Principal investigator, Eva Horová, MD, Charles University, Czech Republic
- Investigators
- Eva Horová, Principal investigator, 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264271
- Sponsor's protocol ID
- GIP-22-NL-06-203
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12364302Shearer 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.
PubMed 15089791Elbalshy 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.
PubMed 35441743Maiorino 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.
PubMed 32312858Vigersky 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.
PubMed 25555391Navratilova 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.
PubMed 40121673
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors
- ClinicalTrials.gov ID
- NCT06264271
- Acronym / sponsor ID
- GIP-22-NL-06-203
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- carbohydrate counting, flexible insulin dosing, structured education, glycemic control, glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with nutrition education | – | Behavioral: structured nutrition interventionPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- uncertain diabetes type
- pregnancy
- change or suspension of glucose sensor monitoring during the study period
- unavailability of sensor data
- automated insulin delivery treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured nutrition interventionStructured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist. | Behavioural | Group with nutrition education |
Primary outcome
difference in HbA1c
Time frame: at month 12
the difference in HbA1c between the groups with and without education
4 secondary outcomes
differences in time in range
Time frame: at month 12
differences in time below range
Time frame: at month 12
differences in time above range
Time frame: at month 12
differences in coefficient of variation
Time frame: at month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 12364302DAFNE 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.
- Background: PubMed 15089791Shearer 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.
- Background: PubMed 35441743Elbalshy 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.
- Background: PubMed 32312858Maiorino 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.
- Background: PubMed 25555391Vigersky 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.
- Derived from this study: PubMed 40121673Navratilova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Horová principal investigator
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in HbA1c (time frame: at month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264271, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.