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Clinical Trials/TCTR20220628003
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

Roche0 sites147 target enrollmentJune 28, 2022

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.

Registry
who.int
Start Date
June 28, 2022
End Date
January 26, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Roche

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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