A Study of the Effect of Blood Glucose Management Using Diet and Continuous Glucose Monitoring on Prevention of Perinatal Complications in Patients with Gestational Diabetes Mellitus

JRCT ID: jRCTs031240590

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gestational diabetes mellitus
• Date of first enrollment: 27/12/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

(1) Comparative study on blood glucose level transition by foods for split meals Step 1 (7 days in total)
Study foods A, B, C, D and conventional diet will be consumed in the early morning at fasting after fasting for more than 6 hours in the first study (Step 1), and the transition of glucose levels before and after the consumption of the study foods will be analyzed by CGM.
(2) Comparative study on blood glucose level transition between 3 times a day diet and 6 times a day diet with spleat meals Step 2 (for a total of 20 days)
Blood glucose fluctuations during the period of normal diet (3 times a day) and 6 times a day split meal diet will be examined using CGM, and TIRs for each diet therapy will be calculated.
In addition to the conventional diet, food A and food D, which contain high fat content and do not easily raise blood glucose levels, are used as snacks in the split meals diet.

Food A: [Lipid-rich food] A food that contains a lot of lipid (80 kcal per serving), which is a commercial product of Ezaki Glico Co., Ltd.
Food B: [Protein-rich food] A food that contains a lot of protein (80 kcal per serving), which is a commercial product of Toyo Suisan Kaisha, Ltd.
Food C: [Dietary fiber-rich foods] A food that contains a lot of dietary fiber (80 kcal per serving), which is a commercial product of Asahi Group Foods, Ltd.
Food D: [Fat and dietary fiber-rich foods] A food that contains a lot of fat and dietary fiber (80 kcal per serving), which is a commercial product of Ezaki Glico Co., Ltd.
Conventional food: conventional carbohydrate- and sugar-rich food (80 kcal per serving) that have been served at Saitama Medical University Hospital in patients with gestational diabetes mellitus

Outcome(s)

• Primary Outcome: Although this study will compare the transition of glucose levels obtained by CGM in the three times daily diet and the six times daily split-meal diet, there are no papers in which the Time in range (TIR), one of the major indexes of CGM and the primary endpoint in this study, was calculated in the six times daily split-meal diet. Therefore, the primary endpoint will be the mean value and 95% confidence interval of the TIR calculated from the transition of glucose levels measured by CGM over 24 hours in the six times daily split-meal diet.

Secondary Outcome

Step 1: Effect of snacking foods on blood glucose levels:
- The maximum change in blood glucose level from baseline (30 minutes before consumption) to within 2 hours after consumption of each food, measured by CGM.
- Time of the maximum change in blood glucose levels from baseline (30 minutes before consumption) to within 2 hours after consumption of each food, measured by CGM.
- AUC of blood glucose levels from baseline (30 minutes before consumption) to within 2 hours after consumption of each food, measured by CGM.
- preference questionnaire

Step 2: Efficacy of split-meals:
- Trends in glucose levels over 24 hours as measured by CGM during the study period comparing the normal diet (3 meals per day) and the six times split meals diet
- % time in range (TIR), which is the time in the range of 72 to 140 mg/dL,
- % time below range (TBR), which is the time of < 72 mg/dL
- % time above range (TAR), which is the time of > 140 mg/dL
- mean glucose value
- fluctuation of glucose level (coefficient of variation / CV)
- the maximum glucose level in 24 hours during the comparison study
- the minimum glucose level in 24 hours during the comparison study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

Outpatients who meet all of the following criteria can be enrolled in this study;
1. patients diagnosed with gestational diabetes mellitus at the Department of Endocrinology and Diabetes, Saitama Medical University Hospital, who are treated with diet and exercise therapy alone or with insulin preparations in addition to diet and exercise therapy
2. patients who are 18 years of age or older at giving their consent
3. patients with a pregnancy between 5 and 28 weeks at giving their consent
4. Patients with HbA1c of 6.4% or less at giving their consent
5. If the patients use insulin, patients who have not changed their insulin dose from 4 weeks prior to the date of consent until the date of consent
6. Patients who give ther consent by written form to participate in this study

Exclude criteria

Patients who fall into any of the following criteria at giving their consent are excluded from participating in this study;
1. Patients obviously diagnosed with diabetes mellitus during pregnancy or diabetic complicated pregnancy
2. Patients using anti-diabetic agents other than insulin
3. Patients obviously diagnosed with pregnancy-induced hypertension
4. Patients using medical agents known to induce abnormal glucose metabolism (psychotropic drugs, corticosteroids, etc.) or suffering from diseases causing secondary diabetes (Cushing's syndrome, primary aldosteronism, endocrine disorders such as hyperthyroidism, liver cirrhosis, chronic pancreatitis, etc.)
5. Patients with possible food allergies to any of the components (e.g., flour, egg, milk, soy, fish meat, etc.) of the study food.
6. Patients with other conditions that the investigator thinks unsuitable for participating in this study

Related Information

• Primary Sponsor: Yasuda Shigemitsu
• Source(s) of Monetary Support: Ezaki Glico Co., Ltd.