The Efficacy of Telemonitoring and Integrated Personalized Diabetes Management (iPDM) in People with Insulin-treated Type 2 Diabetes Mellitus
- Conditions
- DMDM, Telemedicine
- Registration Number
- TCTR20220628003
- Lead Sponsor
- Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 147
1. Age 18-65
2. Has been diagnosed with type 2 diabetes for more than 6 months.
3. Hemoglobin A1C levels were between 7.5-10% within 6 weeks prior to participating in the study.
4. Get Insulin Treatment (either alone or in combination with other oral medications) for at least 3 months
1. Can't penetrate fingertip sugar
2. There is no mobile phone that supports applications and data transmission via the Internet
3. Unable to communicate with the researcher according to the research plan
4. People with a history of taking other drugs that affect glucose levels within 3 months before participating in the study as follows Steroid, Vitamin C excluding vitamin C from natural or fruit sources, Vitamin E, Bactrim, Hydroxyurea
History of diabetic ketoacidosis, hyperglycemic hyperosmolar state in the past 6 months
6. The patient was diagnosed with psychiatric disorders such as depression, bipolar disorder, and schizophrenia.
7. Pregnant or planning to become pregnant within 12 months or breastfeeding
8. Based on the history and clinical manifestations recorded in the medical record Patients with the following chronic diseases Chronic renal failure with a glomerular filtration rate of less than 30 ml/min/1.73 m2, cirrhosis or hepatitis with alanine aminotransferase or aspartate aminotransferase 3 times the upper limit of normal, alcoholism, hypothyroidism with Thyroid values. stimulating hormone greater than 10 uIU/ml, HIV infection, anemia with hemoglobin less than 10 g/dL, iron deficiency, vitamin B12 deficiency, folic acid deficiency, thalassemia, Enzyme Depletion glucose-6-phosphate dehydrogenase, hemolysis and hemoglobin greater than 16 g/dL
9. Have a history of donating blood or received blood in the past 3 months
10. According to medical records, there was uncontrolled diabetic retinopathy or maculopathy.
11. Signs or history of cancer in the 5 years prior to the screening date except for basal cell, squamous cell, and other in situ carcinomas
12. Has a history of major surgery within 90 days or plans to have a major surgery within 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method different of HbA1c 6 months Repeated measure ANOVA
- Secondary Outcome Measures
Name Time Method Percentage of patients with HbA1c lower than 7% at the end of the study 6 months Percentage,Percentage of patients with a more than 0.5% reduction in HbA1c at the end of the study. 6 months Percentage