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:
Condition or disease | Intervention/treatment | Phase |
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Diabetes | Behavioral: Lifestyle intervention with APP | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1336 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Impaired Glucose Tolerance Study (DIGITAL-I Study) |
Actual Study Start Date : | August 3, 2019 |
Estimated Primary Completion Date : | November 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Behavioral intervention
Participants randomized to the behavioral intervention group will be provided with a mobile APP which incorporates behavioral support including health knowledge education, mental health counseling, diet advice, exercise guidance and weight management. Meanwhile, the behavioral support will be modified by endocrinologists, dieticians, sports medicine professionals and psychologists individually based on the feedback of their performance recorded in the APP. 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 and adverse events. Investigators conduct face-to-face health education, lifestyle guidance, 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.
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Behavioral: Lifestyle intervention with APP
The lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP.
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No Intervention: Control group
Participants randomized to the control group 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 and adverse events. 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.
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tianpei Hong, MD,PhD | +8613683265725 ext +8615611908212 | tpho66@bjmu.edu.cn | |
Contact: Jin Yang, PhD | +8615810298367 | yangjin@bjmu.edu.cn |
China, Beijing | |
Peking University Third Hospital YanQing Hospital | Recruiting |
Beijing, Beijing, China | |
Contact: Jinzhan Song, MS +8615811096083 guliangbiao@163.com |
Principal Investigator: | Tianpei Hong, MD,PhD | Peking University Third Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | June 12, 2019 | ||||
First Posted Date ICMJE | June 17, 2019 | ||||
Last Update Posted Date | September 4, 2019 | ||||
Actual Study Start Date ICMJE | August 3, 2019 | ||||
Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The risk of diabetes mellitus (DM) in patients with impaired glucose tolerance [ Time Frame: 2 years ] DM will be diagnosed by a 75g OGTT according to the World Health Organization criteria as fasting plasma glucose level 7.0 mmol/L or more, or 2-hour value 11.1 mmol/L or more. 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Behavioral Intervention to Prevent Impaired Glucose Tolerance Diabetes Mellitus (DIGITAL-I) | ||||
Official Title ICMJE | Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Impaired Glucose Tolerance Study (DIGITAL-I Study) | ||||
Brief Summary |
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:
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Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Diabetes | ||||
Intervention ICMJE | Behavioral: Lifestyle intervention with APP
The lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
1336 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03987438 | ||||
Other Study ID Numbers ICMJE | DIGITAL-I-2019 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Peking University Third Hospital | ||||
Study Sponsor ICMJE | Peking University Third Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Peking University Third Hospital | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |