Type 1 DiabetesNCT05163002
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
A study testing Nutritional education & carbohydrate counting in people with Type 1 Diabetes, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Nutritional education & carbohydrate counting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 10 May 2021to 30 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged ≥18 years old who have been diagnosed with type 1 diabetes or parents of children and adolescents (< 18 years old) who have been diagnosed with type 1 diabetes;
- To be under intensive insulin therapy (basal/bolus system);
- To regularly use a continuous glucose monitoring system as primary method for glycaemic control;
- To be able to read and write.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nutrition Education in Carbohydrate Counting, in a Group Context, on Glycemic Control in People With Type 1 Diabetic
Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Clinical guidelines for the nutritional treatment of diabetes recommend that patients with DM1 learn carbohydrate counting or some similar systematic strategy that allows for better metabolic control. However, despite the recommendations, this is still not a reality for most healthcare services treating individuals diagnosed with DM1.
Read the detailed description
The study aims to assess the impact of a structured nutrition education programme for nutritional education and carbohydrate counting, in group sessions, on glycemic control and nutritional literacy in people with DM1. This will be achieved by evaluating the glycaemic control through A1c and daily glycaemic variability (time on target, mean glycaemia), as well as the level of knowledge before and after the intervention.
- Conditions
- Type 1 Diabetes
- Being tested
- Nutritional education & carbohydrate counting
- 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.
Nutritional education & carbohydrate countingBehavioural
Nutrition Education with a multidisciplinary team
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention arm, uncontrolled Receives: Behavioral: Nutritional education & carbohydrate counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between baseline A1c (%) and 90 days after the last educational session.
The outcome will be assessed through blood exams
Measured: 90 days
Secondary outcomes (4)
Difference in the level of nutritional knowledge assessed through a questionnaire "Nutrition knowledge" collected at baseline and in the last educational session (scale 0 to 23, where 23 is the highest).
The level of knowledge will be measure in a likert scale from 0 (minimum) to 23 (maximum), where a higher score is better than a lower one
Measured: 90 days
Difference in time in range (%) between baseline and 90 days following the last educational session
The outcome will be assessed through data from participants' continuous glucose monitoring system
Measured: 90 days
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
The outcome will be assessed through data from participants' continuous glucose monitoring system
Measured: 90 days
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
The outcome will be assessed through data from participants' continuous glucose monitoring system
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 May 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163002
- Sponsor's protocol ID
- Universidade Nova de Lisboa
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nutrition Education in Carbohydrate Counting, in a Group Context, on Glycemic Control in People With Type 1 Diabetic
- ClinicalTrials.gov ID
- NCT05163002
- Acronym / sponsor ID
- Universidade Nova de Lisboa
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 20 Dec 2021 (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.
Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Clinical guidelines for the nutritional treatment of diabetes recommend that patients with DM1 learn carbohydrate counting or some similar systematic strategy that allows for better metabolic control. However, despite the recommendations, this is still not a reality for most healthcare services treating individuals diagnosed with DM1.
Detailed description
The study aims to assess the impact of a structured nutrition education programme for nutritional education and carbohydrate counting, in group sessions, on glycemic control and nutritional literacy in people with DM1. This will be achieved by evaluating the glycaemic control through A1c and daily glycaemic variability (time on target, mean glycaemia), as well as the level of knowledge before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutritional education & carbohydrate countingIntervention arm, uncontrolled |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years old who have been diagnosed with type 1 diabetes or parents of children and adolescents (< 18 years old) who have been diagnosed with type 1 diabetes;
- To be under intensive insulin therapy (basal/bolus system);
- To regularly use a continuous glucose monitoring system as primary method for glycaemic control;
- To be able to read and write.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nutritional education & carbohydrate countingNutrition Education with a multidisciplinary team | Behavioural | Intervention |
Primary outcome
Differences between baseline A1c (%) and 90 days after the last educational session.
Time frame: 90 days
The outcome will be assessed through blood exams
4 secondary outcomes
Difference in the level of nutritional knowledge assessed through a questionnaire "Nutrition knowledge" collected at baseline and in the last educational session (scale 0 to 23, where 23 is the highest).
Time frame: 90 days
Difference in time in range (%) between baseline and 90 days following the last educational session
Time frame: 90 days
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
Time frame: 90 days
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional education & carbohydrate counting in people with Type 1 Diabetes, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Feb 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 Portugal. 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 was withdrawn before enrolling participants, so there are no results.
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?
Differences between baseline A1c (%) and 90 days after the last educational session. (time frame: 90 days). 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 12 Feb 2026.