Diabetes Mellitus
Conditions
Keywords
nutrition educational program, diabetes, multiple daily injection insulin users
Brief 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. 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
Interventions
OTHERNutrition educational program
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.
Sponsors
Cho Ray Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the difference in the change of HbA1c between the two groups after six months of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in plasma HDL cholesterol (good cholesterol) after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The change in nutrition knowlege at the start of the study and after 6 months between two groups | From enrollment to the end of study at 6 months. | 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. |
| The changes in BMI (Body mass index) after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The changes in Waist Circumference after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The changes in plasma LDL cholesterol (bad cholesterol) after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The changes in plasma total cholesterol after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The changes in plasma triglycerides after six months of follow-up within and between groups | From enrollment to the end of treatment at 6 months | 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. |
| The changes in quality of life after six months of follow-up within and between groups | From enrollment to the end of study at 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change in time in range over six months between groups: standard group and nutrition intervention group | From enrollment to the end of study at six months | We assess blood glucose fluctuations using a flash continuous glucose monitoring system at the start of the study and then every three months for six months. The mean change in time in range within groups will be assessed and compared across the groups. |
| The change in the number of insulin injections per day before and after the intervention between groups | From enrollment to the end of treatment at 6 months | The number of insulin injections per day will be collected each month. The changes in the number of insulin injections per day before and six months after the intervention of the two groups will be compared. |
| The change in the number of anti-diabetic oral medications before and after the intervention between groups | From enrollment to the end of treatment at 6 months | the number of anti-diabetic oral medications will be collected each month. The change in the number of anti-diabetic oral medications before and six months after the intervention of the two groups will be compared |
| The change in time in hyperglycemia over six months between groups: standard group and nutrition intervention group | From enrollment to the end of treatment at 6 months | The mean change in time in hyperglycemia in each group will be assessed and compared between groups. |
| The change in time in hypoglycemia over six months between groups: standard group and nutrition intervention group | From enrollment to the end of treatment at 6 months | The mean change in time in hypoglycemia each groups will be assessed and compared across groups. |
| The change in total daily insulin dose before and after the intervention between groups | From enrollment to the end of study at six months | The total daily insulin dose will be collected each month. The changes in total daily insulin before and six months after the intervention of the two groups will be compared. |
Countries
Vietnam
Contacts
Primary ContactNa Ly Dau, MD
Outcome results
None listed