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The Efficacy of Telemonitoring and Integrated Personalized Diabetes Management (iPDM) in People with Insulin-treated Type 2 Diabetes Mellitus

The Efficacy of Tele-monitoring And Structured Feedback Loop in People with Insulin-treated Type 2 Diabetes Mellitus with Suboptimal Control

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220628003
Enrollment
180
Registered
2022-06-28
Start date
2023-05-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DM DM, Telemedicine

Interventions

Telemedicine,Routine care
iPDM,Control

Sponsors

Roche
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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. 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

Design outcomes

Primary

MeasureTime frame
different of HbA1c 6 months Repeated measure ANOVA

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactThanyalak Saetang

Chulalongkorn Hospital

Thanyalak.saetang@yahoo.com0827348791

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026