TCTR20220628003
Completed
Phase 1
The Efficacy of Tele-monitoring And Structured Feedback Loop in People with Insulin-treated Type 2 Diabetes Mellitus with Suboptimal Control
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- DM
- Sponsor
- Roche
- Enrollment
- 147
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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The impact of a telemetric monitoring service in type 2 diabetesTopic: Diabetes Research Network, Primary Care Research Network for England, Scottish Primary Care Research Network and Scottish Diabetes Research networkSubtopic: Not AssignedDisease: DiabetesNutritional, Metabolic, EndocrineType 2 diabetesISRCTN71674628niversity of Edinburgh (UK)320