Type 1 Diabetes MellitusNCT07834801
Structured Carbohydrate-Counting Education in Adults With Type 1 Diabetes
A study testing Carbohydrate counting education in people with Type 1 Diabetes Mellitus, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Carbohydrate counting education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2022to 21 May 2023
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-65 years
- Diagnosis of type 1 diabetes for at least 1 year
- Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion
- HbA1c ≤10%
- Body mass index (BMI) 19-30 kg/m²
- C-peptide <0.8 ng/mL
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- Use of a continuous glucose monitoring system
- No communication difficulties
- No previous knowledge of carbohydrate counting
- Willingness to receive carbohydrate-counting education
Who cannot join
- Gastroparesis
- Diabetic nephropathy
- Pregnancy
- Celiac disease
- Eating disorder
- Food allergy
Show all 10Show fewer
- Gastrointestinal disease or malabsorption
- Non-adherence to the study protocol
- Withdrawal of informed consent
- Discontinuation of continuous glucose monitoring during follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkish Diabetes Foundation Küçükyalı Internal Medicine Center
Istanbul, Istanbul
About this study
Official title: The Evaluation of the Effects of Structured Carbohydrate-Counting Education on Glycemic Control, Insulin Requirements, Anthropometric Measurements, and Dietary Intake in Adults With Type 1 Diabetes.
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed at baseline and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
Read the detailed description
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed before and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Carbohydrate counting education
- Keywords
- Continuous Glucose Monitoring, Carbohydrate Counting, Glycemic Variability, Nutrition Education, HbA1c, Insulin Dose, Time in Range (TIR)
- 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.
Carbohydrate counting educationBehavioural
Personalized carbohydrate counting training based on the individual's meals, carbohydrate intake, and insulin-to-carbohydrate ratio.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Carbohydrate Counting Education | Experimental | Participants took part in a 12-week individualized carbohydrate-counting training program delivered by a dietitian. The intervention covered carbohydrate counting, the estimation of food and carbohydrate content, and the individualized determination and adjustment of meal-specific insulin-to-carbohydrate ratios. Participants were assessed at baseline and at the end of the 12-week period. Receives: Behavioral: Carbohydrate counting education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time in Range (70-180 mg/dL)
Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values were within the target range of 70-180 mg/dL. Change in TIR was evaluated from baseline to the end of the 12-week intervention.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change in Glycemic Variability
Glycemic variability was assessed using the coefficient of variation (CV) derived from continuous glucose monitoring (CGM) data. Change in CV was evaluated from baseline to the end of the 12-week intervention.
Measured: Baseline and 12 weeks
Change in Laboratory-Measured HbA1c
HbA1c was measured using laboratory analysis. Change in HbA1c was evaluated from baseline to the end of the 12-week intervention.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start8 Feb 2022
- Primary completion21 May 2023
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group, pre-post interventional study in which all participants received the same structured carbohydrate-counting education program. Outcomes were assessed at baseline and after the 12-week intervention.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gözde Arıtıcı Çolak, Associate Professor, Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834801
- Sponsor's protocol ID
- 2021-06-09
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all 30 participants who completed follow-up, including all variables analyzed in the published article and a codebook, will be shared as supplementary material (Supplementary Data S1) with the published article. The SPSS syntax that reproduces the reported analyses will be shared as Supplementary File S1.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Structured Carbohydrate-Counting Education on Glycemic Control, Insulin Requirements, Anthropometric Measurements, and Dietary Intake in Adults With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT07834801
- Acronym / sponsor ID
- 2021-06-09
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Continuous Glucose Monitoring, Carbohydrate Counting, Glycemic Variability, Nutrition Education, HbA1c, Insulin Dose, Time in Range (TIR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 22 Sep 2026 (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.
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed at baseline and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
Detailed description
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed before and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group, pre-post interventional study in which all participants received the same structured carbohydrate-counting education program. Outcomes were assessed at baseline and after the 12-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Individualized Carbohydrate Counting Education | Experimental | Behavioral: Carbohydrate counting educationParticipants took part in a 12-week individualized carbohydrate-counting training program delivered by a dietitian. The intervention covered carbohydrate counting, the estimation of food and carbohydrate content, and the individualized determination and adjustment of meal-specific insulin-to-carbohydrate ratios. Participants were assessed at baseline and at the end of the 12-week period. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 19-65 years
- Diagnosis of type 1 diabetes for at least 1 year
- Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion
- HbA1c ≤10%
- Body mass index (BMI) 19-30 kg/m²
Key exclusion criteria (10 listed)
- Gastroparesis
- Diabetic nephropathy
- Pregnancy
- Celiac disease
- Eating disorder
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 |
|---|---|---|
| Carbohydrate counting educationPersonalized carbohydrate counting training based on the individual's meals, carbohydrate intake, and insulin-to-carbohydrate ratio. | Behavioural | Individualized Carbohydrate Counting Education |
Primary outcome
Change in Time in Range (70-180 mg/dL)
Time frame: Baseline and 12 weeks
Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values were within the target range of 70-180 mg/dL. Change in TIR was evaluated from baseline to the end of the 12-week intervention.
2 secondary outcomes
Change in Glycemic Variability
Time frame: Baseline and 12 weeks
Change in Laboratory-Measured HbA1c
Time frame: Baseline and 12 weeks
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all 30 participants who completed follow-up, including all variables analyzed in the published article and a codebook, will be shared as supplementary material (Supplementary Data S1) with the published article. The SPSS syntax that reproduces the reported analyses will be shared as Supplementary File S1.
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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.
Gözde Arıtıcı Çolak, Associate Professor study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate counting education in people with Type 1 Diabetes Mellitus, run by Acibadem University at 1 site in Turkey (Türkiye).
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 10 inclusion and 10 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 26 Oct 2026. 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 Turkey (Türkiye). 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?
Change in Time in Range (70-180 mg/dL) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.