Efficacy of MLink based telemedicine on GDM in a randomized controlled trial

JRCT ID: jRCT1032230258

Registered date:26/07/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Gestational Diabetes
• Date of first enrollment: 26/07/2023
• Target sample size: 140
• Study type: Interventional

Intervention(s)

Participants are randomized into two groups. A standard medical care group and an intervention group that uses the MLink application and recommends online medical care.

The standard care group
In the standard care group, gestational diabetes management is conducted in accordance with the Obstetric Guidelines 2020. The standard treatment group provides treatment including insulin therapy through diet and exercise therapy and referral to a diabetologist as necessary. However, the medical treatment system should be face to face only, and in principle, one of the following is recommended for the frequency of blood glucose monitoring.
1. 6 times per day before each meal or 2 hours after each meal
2. 4 times per day before breakfast and 2 hours after each meal

The intervention group
In the intervention group, study subjects are to use the MLink downloaded to their smartphones from the day of enrollment until 14 days after the day of enrollment during the intervention period. Medical care providers distribute medical information and laboratory data forms with QR codes that can be issued from obstetric charts at each visit, and study subjects store the medical information by reading it with the MLink app. In addition, home information such as diet, blood glucose, insulin dosage, blood pressure, weight, and step count will also be recorded in the MLink. If the research participant wishes, and if the physician determines that there is no medical problem, he or she can receive medical care or nutritional guidance from a diabetes physician via online medical care. In such cases, it is recommended that the medical practitioner refer to the medical and home information stored in MLink, which is set up with the consent of the Advanced privacy preference manager of the research subject before providing the online medical care. Diet, exercise, insulin therapy and blood glucose monitoring should comply with the Obstetrics Guidelines 2020, as in the standard practice group.

Outcome(s)

• Primary Outcome: Percentage out of target blood glucose range at 2 h postprandial: Percentage of self-measured blood glucose levels that were out of target range during the protocol treatment period.

Secondary Outcome

Secondary endpoints
*Percentage out of target blood glucose range before meal
*Average blood glucose level
*Adherence to blood glucose monitoring
*HbA1c change during protocol treatment
*Weight change from non-pregnant to pre-partum
*Insulin therapy during the protocol treatment period
*Gestational hypertension, gestational hypertension nephropathy
*Weeks of birth
*Preterm birth, late preterm birth
*Mode of delivery
*Questionnaire in postpartum and at the time of discontinuation of the study
*Fetal birth weight
*Small for Gestational Age (SGA), Large for Gestational Age (LGA)
*Fetal macrosomia
*Apgar score in 1min and 5 min
*Composite outcome of neonatal complications

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Female

Include criteria

Study subjects who meet all of the following selection and diagnostic criteria and none of the exclusion criteria will be enrolled as eligible.

Selection Criteria
1. Fluent in Japanese
2. Single pregnancy
3. Age between 18 and 45 years at the time of consent
4. Pregnancy of less than 35 weeks and 0 days at the time of consent
5. Scheduled to give birth at Saitama Medical University General Hospital, Aiwa Hospital, Keiai Hospital, or Seto Hospital
6. Patients diagnosed with gestational diabetes mellitus based on IADPSG diagnostic criteria by a 75g oral glucose tolerance test between 24 weeks 0 days and 28 weeks 6 days of pregnancy

Diagnostic criteria for gestational diabetes mellitus based on IADPSG criteria
Diagnosis is made when one or more of the following criteria are met in a 75g OGTT.
Fasting plasma glucose level >= 92mg/dL
1 hour value >=180mg/dL
2 hour value >=153mg/dL

Exclude criteria

Exclusion Criteria:
1. Any indication of hypertension before or by 19 weeks and 6 days including 19 weeks and 6 days of gestation of pregnancy
2.Serious history of cardiac, hepatic, or renal disease
3. Eating disorders.
4. Does not have a smartphone compatible with MLink to be used in this study or otherwise is unable to operate or view the data on her/his own
5. Research subjects who are deemed inappropriate for the safe conduct of this study by the Principal Investigator or Research Supervisor.

Related Information

• Primary Sponsor: IZUMIDA Yoshihiko
• Source(s) of Monetary Support: n/a