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Effectiveness of continuous digital health support for glycemic control in type 2 diabetes with mild cognitive impairment

Effectiveness of continuous digital health support for glycemic control in type 2 diabetes with mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121002
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-27
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Type 2 diabetes

Interventions

Control group:Intensive education based on 14-day continuous glucose monitoring data
Experimental group:Intensive education combined with ongoing digital health support based on 14-day continuous glucose monitoring data

Sponsors

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 40–80 years; 2. Meets the diagnostic criteria for type 2 diabetes mellitus (T2DM) and has a glycated hemoglobin (HbA1c) level of >=7.5%; 3. Has completed at least 6 years of education; 4. Possesses basic smartphone operation skills; 5. Meets the Peterson diagnostic criteria for mild cognitive impairment; 6. Voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Possible dementia; 2. A history of severe acute or chronic diabetic complications within the past 3 months, such as diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemic coma, or end-stage renal disease (eGFR < 15 mL/min/1.73 m² or undergoing dialysis); 3. Uncontrolled thyroid disease or other endocrine disorders; 4. History of steroid therapy; 5. A history of established neurological or psychiatric disorders, such as brain tumors, cerebral infarction, cerebral hemorrhage, delirium, or depression; 6. Other major systemic diseases that may independently cause cognitive impairment, such as severe liver disease (e.g., Child-Pugh Class B or higher), active autoimmune diseases or chronic inflammatory diseases, or untreated or uncontrolled sleep apnea syndrome; 7. Alcohol or substance abuse; 8. Use of medications associated with cognitive effects; 9. Inability to complete cognitive testing; 10. Severe impairment of vision, hearing, or communication abilities.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin;

Secondary

MeasureTime frame
Blood glucose management indicators;Changes in body composition;Changes in blood lipid levels;Changes in cognitive function;Changes in diet;Changes in excercise;Compliance assessment;

Countries

China

Contacts

Public ContactYuqian Bao

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

byq522@163.com+86 21 6436 9181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026