A Behavioral Intervention to Prevent Impaired Glucose Tolerance Diabetes Mellitus (DIGITAL-I)
A Behavioral Intervention to Prevent Impaired Glucose Tolerance Diabetes Mellitus (DIGITAL-I)
The national epidemiological survey showed that the prevalence rate of pre-diabetes was up to
 35.7% in China. Previous study indicated that lifestyle intervention in people with impaired
 glucose tolerance could delay the onset of type 2 diabetes. However, patients with
 pre-diabetes do not pay enough attention to their glucose metabolism, and most of them rarely
 monitor their blood glucose. With the increasing use of smartphones, mobile applications
 (APPs) can be applied in the education and management of chronic diseases, including
 diabetes. Thus, the investigators will conduct a multi-centered, two-armed, open-labeled,
 randomized controlled trial to evaluate whether the behavioral intervention by a mobile APP
 can prevent the occurrence of diabetes in people with impaired glucose tolerance.

 The investigators hypothesize that behavioral intervention in pre-diabetes with using a
 mobile APP that incorporates nutrition, exercise and psychological support from trained
 professional doctors will:

 1. Reduce the risk of the onset of diabetes in people with impaired glucose tolerance.

 2. Increase the reversal rate of becoming normal glucose tolerance and reduce the levels of
 glycosylated hemoglobin in pre-diabetes.
Participants from fourteen research centers in the mainland of China will be recruited in the
 study. People will be screened for a 75g oral glucose tolerance test (OGTT). The patients
 whose fasting glucose between 6.1mmol/L and 7.0mmol/L or 2-hour value between 7.8mmol/L and
 11.1mmol/L will be diagnosed with impaired glucose tolerance and recommended to participate
 in the study.

 People who meet the eligibility criteria and who are willing to provide informed consent will
 be enrolled and randomized to behavioral intervention group and control group. People in the
 behavioral intervention group will be educated and monitored by a mobile APP that provides
 behavioral support including health knowledge education, mental health counseling, smart diet
 advice, intelligent exercise guidance, and target weight management. Meanwhile, the
 behavioral support will be modified by endocrinologists, dieticians, sports medicine
 professionals and psychologists individually based on the feedback of their characteristics
 and performance recorded in the APP. Participants randomized to the control group only have
 regular care in their local hospitals.

 Every three months, participants in the intervention group will be back to their research
 centers and be collected with information including HbA1c levels, blood pressure, heart rate
 tests, adverse events, combined medications and health checklists. Investigators conduct
 face-to-face health education, lifestyle guidance and mobile APP software inspection. Every
 one year, 75g OGTT (0min, 60min, 120min points of blood glucose and insulin levels), liver
 and kidney function, blood lipids, glycosylated hemoglobin, urine routine and
 electrocardiogram will be evaluated in both of the group. Investigators will compare the
 diabetes risk in the two groups to evaluate whether behavioral intervention with a mobile APP
 can reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
 Investigators also will compare the reversal rate of becoming normal glucose tolerance in
 prediabetes and the changes of glycosylated hemoglobin levels in both groups. Behavioral
 intervention with the APP will last for two years.
Inclusion Criteria:

 -  Age between 18 and 70 years old

 -  Impaired glucose tolerance will be diagnosed by a 75g OGTT according to the criteria
 of World Health Organization as a fasting plasma glucose level between 6.1 mmol/L and
 7.0 mmol/L, or 2-hour value between 7.8 mmol/L and 11.1 mmol/L

 -  Willing to keep reading the education articles and supporting materials that delivered
 by the mobile APP

 -  Willing to provide informed consent

 Exclusion Criteria:

 -  Pregnant women, pregnant or lactating women (Can be reassessed after childbirth or
 after breastfeeding)

 -  Inconvenient to move, far away from the center to limit follow-up, more than 2 hours
 drive from the center

 -  Cannot complete the test because of planning migration

 -  Schizophrenia, manic depression, drug or alcohol addicts

 -  Cancer patients who have been treated in the past 5 years

 -  HIV positive (report)

 -  Active tuberculosis

 -  Patients with severe CVD (Myocardial infarction, heart failure, stroke) or pulmonary
 embolism in the past 6 months

 -  Unstable angina or resting angina; history of cardiac arrest; severe arrhythmia;
 uncontrolled atrial fibrillation (heart rate not less than 100 beats / min); cardiac
 function by New York Cardiology Society Grade III ~ IV; acute myocarditis,
 pericarditis or hypertrophic cardiomyopathy; clinically significant aortic stenosis;
 severe left bundle branch block or installation of a pacemaker (unless agreed by a
 cardiologist); history of defibrillation; aortic aneurysm diameter > 7cm or history of
 aortic rupture; history of heart transplantation; resting heart rate <45 beats / min
 or > 100 beats / min

 -  Cirrhosis; Cushing's syndrome; acromegaly; long-term application of glucocorticoids

 -  Serum creatinine is 2 times higher than the upper limit of normal; currently
 undergoing dialysis

 -  Chronic anoxia diseases such as emphysema, pulmonary heart disease, etc.

 -  Rheumatic heart disease; congenital heart disease

 -  Organ transplantation patients