Diabetes MellitusNCT06985095
Evaluation of a Structured Nutrition Educational Program in Insulin-treated Diabetic Patients in Vietnam
A study testing Nutrition educational program in people with Diabetes Mellitus, run by Cho Ray Hospital at 1 site in Vietnam.
Trial summary
The purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better. This study is for men and women between 18 and 70 years old who use insulin at least twice a day but still have high blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Nutrition educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Apr 2025to 1 Mar 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People between 18 and 70 years old.
- People who come to Cho Ray Hospital for diabetes care and plan to keep getting care there for at least six months.
- People who have diabetes and have been prescribed diabetes medicine.
- People who were recently diagnosed with diabetes, based on the latest guidelines from the American Diabetes Association.
- People whose blood sugar (HbA1c) level is higher than 8%.
- People who are currently using at least two insulin injections a day or have just started a daily multiple insulin injection plan because their diabetes is not well controlled.
Who cannot join
- People who are seriously ill and need to stay in the hospital, such as those with infections, pneumonia, heart attacks, strokes, or infected diabetic foot.
- People who have cancer, serious mental health problems, or problems with drug use.
- People who do not want to take part or cannot follow the study plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Structured Nutrition Educational Program on Glycemic Control, Quality of Life, and Cardiovascular Risk in Patients With Uncontrolled Diabetes Using Multiple Daily Insulin Injections
The purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better.
This study is for men and women between 18 and 70 years old who use insulin at least twice a day but still have high blood sugar.
Read more
We want to answer the following questions:
Can nutrition education help lower HbA1c (a blood test that shows average blood sugar over the past 3 months)? Can it improve knowledge about nutrition, quality of life, and make blood sugar more stable? Will it help reduce fasting blood sugar, lipid levels, body weight, and the number of times low blood sugar (hypoglycemia) happens?
Participants will be divided into two groups:
One group will receive a nutrition booklet. The other group will receive the same booklet and join four monthly lessons with a researcher.
The four lessons will talk about:
Goals for managing diabetes Main nutrients in food How to plan meals How to eat in a way that supports better blood sugar control
Read the detailed description
This study will involve 115 people with diabetes who need to take insulin at least twice a day. It includes those who already use multiple insulin injections but still have high blood sugar, and those who are newly switched to at least two insulin shots daily because their blood sugar is not well controlled with pills or pills plus one injection.
The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2025 to the end of 2026. People will be invited to join at the Endocrinology Consultation Unit. If they agree, their phone number will be collected and the research team will call them later to explain more about the study. If they are still interested, they'll be asked to keep a food diary for three days before their screening.
On the screening day, they'll sign a short consent form, get blood tests to check their sugar, HbA1c, cholesterol, and kidney function, talk with a nutrition researcher about their food diary, and have a usual consultation with their doctor. If they meet all the criteria and agree to take part, they'll sign the full consent form and take short tests on nutrition knowledge and quality of life. The quality of life questionnaire used is the SF-36 questionnaire, and nutrition knowledge is assessed using the Diabetes-related Nutrition Knowledge Questionnaire (DRNK-Q).
After that, they will be randomly assigned to one of two groups. One group will get a nutrition booklet only. The other group will receive the booklet plus attend four monthly sessions with a researcher to learn about healthy eating for diabetes. In each group, 10 participants will also wear a flash glucose monitor (a small device that checks sugar levels without finger pricks) three times: at the beginning, after 3 months, and after 6 months. These participants will be selected based on age, HbA1c level, ability to use the device, and whether they often experience low blood sugar.
During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; they will be asked monthly about any low blood sugar episodes; they will repeat the nutrition and quality of life tests at 6 months; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study
- Conditions
- Diabetes Mellitus
- Being tested
- Nutrition educational program
- Keywords
- nutrition educational program, diabetes, multiple daily injection insulin users
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educational programOther
Participants in the intervention group will attend a structured nutrition education program consisting of four monthly sessions, each lasting approximately 40 to 60 minutes. These sessions will be conducted in small groups by the researcher.
Each session includes: A 20-30 minute presentation delivered by the researcher using visual aids, such as slides and educational images. A 20-30 minute interactive discussion to address participants' questions, clarify concepts.
Session Topics:
Treatment Goals in Diabetes Care: Overview of blood glucose targets and the importance of achieving glycemic control.
Key Nutritional Components of Food: Roles of carbohydrates, proteins, fats, fiber, and their impact on blood glucose.
Principles of Meal Planning: Adjusting energy intake based on physical activity levels and BMI.
Understanding the Food Exchange System: Introduction to food exchange lists; selecting the appropriate number of food exchanges to meet individual energy needs.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | Participants in this arm only receive a nutrition booklet, written and designed by researchers. They don't join the lessons with the researcher. |
| Nutrition Intervention group | Experimental | Intervention group receives the same booklet and attends four monthly lessons with a researcher about healthy eating for diabetes. Receives: Other: Nutrition educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in the change of HbA1c between the two groups after six months of follow-up
We will check each person's HbA1c level before starting the program, and then again every three months. After six months, we will look at how much each person's HbA1c has changed compared to the beginning. Then we'll compare the average change between the two groups using a statistical test.
Measured: For enrollment to the end of study at 6 months
Secondary outcomes (8)
The changes in quality of life after six months of follow-up within and between groups
Quality of life will be assessed at the start of the study and again after six months using the SF-36 questionnaire. The total scores from the questionnaire will be calculated, and the average change in scores will be compared between the two groups.
Measured: From enrollment to the end of study at 6 months
The change in nutrition knowlege at the start of the study and after 6 months between two groups
Nutrition knowledge will be assessed using the Diabetes-related Nutrition Knowledge questionnaire (DRNK-Q) at the start of the study and again after six months. The mean change in total score of the questionnaire before and after six months will be compared between the two groups. The maximum score is 27 for the people who consume alcohol, and is 25 for the people who don't consume alcohol. The minimum score is zero. The higher score indicates an improvement in nutritional knowledge.
Measured: From enrollment to the end of study at 6 months.
The changes in BMI (Body mass index) after six months of follow-up within and between groups
BMI will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
The changes in Waist Circumference after six months of follow-up within and between groups
Waist Circumference will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
The changes in plasma LDL cholesterol (bad cholesterol) after six months of follow-up within and between groups
Plasma LDL cholesterol (bad cholesterol) will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
The changes in plasma total cholesterol after six months of follow-up within and between groups
Plasma total cholesterol will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
The changes in plasma triglycerides after six months of follow-up within and between groups
Plasma triglycerides will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
The changes in plasma HDL cholesterol (good cholesterol) after six months of follow-up within and between groups
Plasma HDL cholesterol (good cholesterol) will be measured at the beginning of the study and every three months. Changes in these health indicators over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start4 Apr 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cho Ray Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ly Na Dau, Cho Ray Hospital
- Investigators
- Na Ly Dau, MD, Principal investigator, Cho Ray Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985095
- Sponsor's protocol ID
- ChorayMUIN2025
- Status last verified
- Sep 2026
- First submitted
- 5 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data (IPD) collected during the study will be made publicly available upon reasonable request or through a designated open-access repository after publication of the main results. Data will be shared in compliance with ethical approvals and participant consent, ensuring that no personally identifiable information is disclosed.
Publications
Bowen ME, Cavanaugh KL, Wolff K, Davis D, Gregory RP, Shintani A, Eden S, Wallston K, Elasy T, Rothman RL. The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education. Patient Educ Couns. 2016 Aug;99(8):1368-76. doi: 10.1016/j.pec.2016.03.017. Epub 2016 Mar 19.
PubMed 27026388Speight J, Amiel SA, Bradley C, Heller S, Oliver L, Roberts S, Rogers H, Taylor C, Thompson G. Long-term biomedical and psychosocial outcomes following DAFNE (Dose Adjustment For Normal Eating) structured education to promote intensive insulin therapy in adults with sub-optimally controlled Type 1 diabetes. Diabetes Res Clin Pract. 2010 Jul;89(1):22-9. doi: 10.1016/j.diabres.2010.03.017. Epub 2010 Apr 18.
PubMed 20399523Trento M, Trinetta A, Kucich C, Grassi G, Passera P, Gennari S, Paganin V, Tedesco S, Charrier L, Cavallo F, Porta M. Carbohydrate counting improves coping ability and metabolic control in patients with Type 1 diabetes managed by Group Care. J Endocrinol Invest. 2011 Feb;34(2):101-5. doi: 10.1007/BF03347038. Epub 2010 May 3.
PubMed 20440106Schmidt S, Schelde B, Norgaard K. Effects of advanced carbohydrate counting in patients with type 1 diabetes: a systematic review. Diabet Med. 2014 Aug;31(8):886-96. doi: 10.1111/dme.12446.
PubMed 24654856Franz MJ, MacLeod J, Evert A, Brown C, Gradwell E, Handu D, Reppert A, Robinson M. Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. J Acad Nutr Diet. 2017 Oct;117(10):1659-1679. doi: 10.1016/j.jand.2017.03.022. Epub 2017 May 19. No abstract available.
PubMed 28533169Franz MJ, Monk A, Barry B, McClain K, Weaver T, Cooper N, Upham P, Bergenstal R, Mazze RS. Effectiveness of medical nutrition therapy provided by dietitians in the management of non-insulin-dependent diabetes mellitus: a randomized, controlled clinical trial. J Am Diet Assoc. 1995 Sep;95(9):1009-17. doi: 10.1016/S0002-8223(95)00276-6.
PubMed 7657902Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. BMJ. 2010 Jul 20;341:c3337. doi: 10.1136/bmj.c3337.
PubMed 20647285Kitajima Y, Mikami N, Hyodo T, Hida M, Kawakami J. Carbohydrate Counting: A Simple Method of Dietary Management for Glycemic Control in Japanese Diabetic Hemodialysis Patients. Contrib Nephrol. 2017;189:262-269. doi: 10.1159/000451045. Epub 2016 Dec 12.
PubMed 27951578Laurenzi A, Bolla AM, Panigoni G, Doria V, Uccellatore A, Peretti E, Saibene A, Galimberti G, Bosi E, Scavini M. Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR). Diabetes Care. 2011 Apr;34(4):823-7. doi: 10.2337/dc10-1490. Epub 2011 Mar 4.
PubMed 21378215Cadario F, Prodam F, Pasqualicchio S, Bellone S, Bonsignori I, Demarchi I, Monzani A, Bona G. Lipid profile and nutritional intake in children and adolescents with Type 1 diabetes improve after a structured dietician training to a Mediterranean-style diet. J Endocrinol Invest. 2012 Feb;35(2):160-8. doi: 10.3275/7755. Epub 2011 May 27.
PubMed 21623150Powers MA, Gal RL, Connor CG, Mangan M, Maahs DM, Clements MA, Mayer-Davis EJ. Eating patterns and food intake of persons with type 1 diabetes within the T1D exchange. Diabetes Res Clin Pract. 2018 Jul;141:217-228. doi: 10.1016/j.diabres.2018.05.011. Epub 2018 May 26.
PubMed 29772288DAFNE 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 12364302Andrews RC, Cooper AR, Montgomery AA, Norcross AJ, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Bright J, Coulman K, England CY, Gorton J, McLenaghan A, Paxton E, Polet A, Thompson C, Dayan CM. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial. Lancet. 2011 Jul 9;378(9786):129-39. doi: 10.1016/S0140-6736(11)60442-X. Epub 2011 Jun 24.
PubMed 21705068Franz MJ, Powers MA, Leontos C, Holzmeister LA, Kulkarni K, Monk A, Wedel N, Gradwell E. The evidence for medical nutrition therapy for type 1 and type 2 diabetes in adults. J Am Diet Assoc. 2010 Dec;110(12):1852-89. doi: 10.1016/j.jada.2010.09.014.
PubMed 21111095Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, Ludwig B, Norgaard K, Pettus J, Renard E, Skyler JS, Snoek FJ, Weinstock RS, Peters AL. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021 Dec;64(12):2609-2652. doi: 10.1007/s00125-021-05568-3.
PubMed 34590174
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Nutrition Educational Program on Glycemic Control, Quality of Life, and Cardiovascular Risk in Patients With Uncontrolled Diabetes Using Multiple Daily Insulin Injections
- ClinicalTrials.gov ID
- NCT06985095
- Acronym / sponsor ID
- ChorayMUIN2025
- Conditions
- Diabetes Mellitus
- Keywords
- nutrition educational program, diabetes, multiple daily injection insulin users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cho Ray HospitalUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 22 May 2025 (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 purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better.
This study is for men and women between 18 and 70 years old who use insulin at least twice a day but still have high blood sugar.
We want to answer the following questions:
Can nutrition education help lower HbA1c (a blood test that shows average blood sugar over the past 3 months)? Can it improve knowledge about nutrition, quality of life, and make blood sugar more stable? Will it help reduce fasting blood sugar, lipid levels, body weight, and the number of times low blood sugar (hypoglycemia) happens?
Participants will be divided into two groups:
One group will receive a nutrition booklet. The other group will receive the same booklet and join four monthly lessons with a researcher.
The four lessons will talk about:
Goals for managing diabetes Main nutrients in food How to plan meals How to eat in a way that supports better blood sugar control
Detailed description
This study will involve 115 people with diabetes who need to take insulin at least twice a day. It includes those who already use multiple insulin injections but still have high blood sugar, and those who are newly switched to at least two insulin shots daily because their blood sugar is not well controlled with pills or pills plus one injection.
The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2025 to the end of 2026. People will be invited to join at the Endocrinology Consultation Unit. If they agree, their phone number will be collected and the research team will call them later to explain more about the study. If they are still interested, they'll be asked to keep a food diary for three days before their screening.
On the screening day, they'll sign a short consent form, get blood tests to check their sugar, HbA1c, cholesterol, and kidney function, talk with a nutrition researcher about their food diary, and have a usual consultation with their doctor. If they meet all the criteria and agree to take part, they'll sign the full consent form and take short tests on nutrition knowledge and quality of life. The quality of life questionnaire used is the SF-36 questionnaire, and nutrition knowledge is assessed using the Diabetes-related Nutrition Knowledge Questionnaire (DRNK-Q).
After that, they will be randomly assigned to one of two groups. One group will get a nutrition booklet only. The other group will receive the booklet plus attend four monthly sessions with a researcher to learn about healthy eating for diabetes. In each group, 10 participants will also wear a flash glucose monitor (a small device that checks sugar levels without finger pricks) three times: at the beginning, after 3 months, and after 6 months. These participants will be selected based on age, HbA1c level, ability to use the device, and whether they often experience low blood sugar.
During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; they will be asked monthly about any low blood sugar episodes; they will repeat the nutrition and quality of life tests at 6 months; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –Participants in this arm only receive a nutrition booklet, written and designed by researchers. They don't join the lessons with the researcher. |
| Nutrition Intervention group | Experimental | Other: Nutrition educational programIntervention group receives the same booklet and attends four monthly lessons with a researcher about healthy eating for diabetes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People between 18 and 70 years old.
- People who come to Cho Ray Hospital for diabetes care and plan to keep getting care there for at least six months.
- People who have diabetes and have been prescribed diabetes medicine.
- People who were recently diagnosed with diabetes, based on the latest guidelines from the American Diabetes Association.
- People whose blood sugar (HbA1c) level is higher than 8%.
Key exclusion criteria (3 listed)
- People who are seriously ill and need to stay in the hospital, such as those with infections, pneumonia, heart attacks, strokes, or infected diabetic foot.
- People who have cancer, serious mental health problems, or problems with drug use.
- People who do not want to take part or cannot follow the study plan.
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 |
|---|---|---|
| Nutrition educational programParticipants in the intervention group will attend a structured nutrition education program consisting of four monthly sessions, each lasting approximately 40 to 60 minutes. These sessions will be conducted in small groups by the researcher. Each session includes: A 20-30 minute presentation delivered by the researcher using visual aids, such as slides and educational images. A 20-30 minute interactive discussion to address participants' questions, clarify concepts. Session Topics: Treatment Goals in Diabetes Care: Overview of blood glucose targets and the importance of achieving glycemic control. Key Nutritional Components of Food: Roles of carbohydrates, proteins, fats, fiber, and their impact on blood glucose. Principles of Meal Planning: Adjusting energy intake based on physical activity levels and BMI. Understanding the Food Exchange System: Introduction to food exchange lists; selecting the appropriate number of food exchanges to meet individual energy needs. | Other | Nutrition Intervention group |
Primary outcome
the difference in the change of HbA1c between the two groups after six months of follow-up
Time frame: For enrollment to the end of study at 6 months
We will check each person's HbA1c level before starting the program, and then again every three months. After six months, we will look at how much each person's HbA1c has changed compared to the beginning. Then we'll compare the average change between the two groups using a statistical test.
8 secondary outcomes
The changes in quality of life after six months of follow-up within and between groups
Time frame: From enrollment to the end of study at 6 months
The change in nutrition knowlege at the start of the study and after 6 months between two groups
Time frame: From enrollment to the end of study at 6 months.
The changes in BMI (Body mass index) after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
The changes in Waist Circumference after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma LDL cholesterol (bad cholesterol) after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma total cholesterol after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma triglycerides after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma HDL cholesterol (good cholesterol) after six months of follow-up within and between groups
Time frame: From enrollment to the end of treatment at 6 months
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 22 Oct 2026.
- Background: PubMed 27026388Bowen ME, Cavanaugh KL, Wolff K, Davis D, Gregory RP, Shintani A, Eden S, Wallston K, Elasy T, Rothman RL. The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education. Patient Educ Couns. 2016 Aug;99(8):1368-76. doi: 10.1016/j.pec.2016.03.017. Epub 2016 Mar 19.
- Background: PubMed 20399523Speight J, Amiel SA, Bradley C, Heller S, Oliver L, Roberts S, Rogers H, Taylor C, Thompson G. Long-term biomedical and psychosocial outcomes following DAFNE (Dose Adjustment For Normal Eating) structured education to promote intensive insulin therapy in adults with sub-optimally controlled Type 1 diabetes. Diabetes Res Clin Pract. 2010 Jul;89(1):22-9. doi: 10.1016/j.diabres.2010.03.017. Epub 2010 Apr 18.
- Background: PubMed 20440106Trento M, Trinetta A, Kucich C, Grassi G, Passera P, Gennari S, Paganin V, Tedesco S, Charrier L, Cavallo F, Porta M. Carbohydrate counting improves coping ability and metabolic control in patients with Type 1 diabetes managed by Group Care. J Endocrinol Invest. 2011 Feb;34(2):101-5. doi: 10.1007/BF03347038. Epub 2010 May 3.
- Background: PubMed 24654856Schmidt S, Schelde B, Norgaard K. Effects of advanced carbohydrate counting in patients with type 1 diabetes: a systematic review. Diabet Med. 2014 Aug;31(8):886-96. doi: 10.1111/dme.12446.
- Background: PubMed 28533169Franz MJ, MacLeod J, Evert A, Brown C, Gradwell E, Handu D, Reppert A, Robinson M. Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. J Acad Nutr Diet. 2017 Oct;117(10):1659-1679. doi: 10.1016/j.jand.2017.03.022. Epub 2017 May 19. No abstract available.
- Background: PubMed 7657902Franz MJ, Monk A, Barry B, McClain K, Weaver T, Cooper N, Upham P, Bergenstal R, Mazze RS. Effectiveness of medical nutrition therapy provided by dietitians in the management of non-insulin-dependent diabetes mellitus: a randomized, controlled clinical trial. J Am Diet Assoc. 1995 Sep;95(9):1009-17. doi: 10.1016/S0002-8223(95)00276-6.
- Background: PubMed 20647285Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. BMJ. 2010 Jul 20;341:c3337. doi: 10.1136/bmj.c3337.
- Background: PubMed 27951578Kitajima Y, Mikami N, Hyodo T, Hida M, Kawakami J. Carbohydrate Counting: A Simple Method of Dietary Management for Glycemic Control in Japanese Diabetic Hemodialysis Patients. Contrib Nephrol. 2017;189:262-269. doi: 10.1159/000451045. Epub 2016 Dec 12.
- Background: PubMed 21378215Laurenzi A, Bolla AM, Panigoni G, Doria V, Uccellatore A, Peretti E, Saibene A, Galimberti G, Bosi E, Scavini M. Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR). Diabetes Care. 2011 Apr;34(4):823-7. doi: 10.2337/dc10-1490. Epub 2011 Mar 4.
- Background: PubMed 21623150Cadario F, Prodam F, Pasqualicchio S, Bellone S, Bonsignori I, Demarchi I, Monzani A, Bona G. Lipid profile and nutritional intake in children and adolescents with Type 1 diabetes improve after a structured dietician training to a Mediterranean-style diet. J Endocrinol Invest. 2012 Feb;35(2):160-8. doi: 10.3275/7755. Epub 2011 May 27.
- Background: PubMed 29772288Powers MA, Gal RL, Connor CG, Mangan M, Maahs DM, Clements MA, Mayer-Davis EJ. Eating patterns and food intake of persons with type 1 diabetes within the T1D exchange. Diabetes Res Clin Pract. 2018 Jul;141:217-228. doi: 10.1016/j.diabres.2018.05.011. Epub 2018 May 26.
- 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.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data (IPD) collected during the study will be made publicly available upon reasonable request or through a designated open-access repository after publication of the main results. Data will be shared in compliance with ethical approvals and participant consent, ensuring that no personally identifiable information is disclosed.
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Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Na Ly Dau, MD principal investigator
Cho Ray Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition educational program in people with Diabetes Mellitus, run by Cho Ray Hospital at 1 site in Vietnam.
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 6 inclusion and 3 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 22 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 Vietnam. 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?
the difference in the change of HbA1c between the two groups after six months of follow-up (time frame: For enrollment to the end of study at 6 months). 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 NCT06985095, which also lists 15 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 22 Oct 2026.