The GLITTER Study 2 is a cluster randomized trial that will evaluate the impact of comprehensive and intensive management, comprising a team, technology, education, and peer resources, on metabolic control and psychological outcomes in patients with type 1 diabetes.
Members of the China Diabetes Type 1 Study (CD1S).
Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.
Have type 1 diabetes educators.
Diagnosis of Type 1 Diabetes.
Patients who plan to receive diabetes treatment at other hospitals.
Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.
Parallel
T1D team, structured education, peer support , and diabetes technologies
BehavioralPatients with T1D will use insulin pumps and CGM , while undergoing structured education courses under the management of a specialized T1D team and engaging in peer support activities.
Routine Management
BehavioralPatients with T1D will be managed according to the routine diagnosis and education model of each hospital.
Change in HbA1c
The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c) before and after the 52 weeks intervention. HbA1c is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.
Percentage of patients in each group with HbA1c <7.0%
HbA1c serves as a crucial physiological marker for assessing average blood sugar levels over the preceding three months. Values below 7.0 are deemed optimal for long-term health. Consequently, a higher number or percentage of individuals achieving an HbA1c level below 7.0 is indicative of a positive outcome, reflecting better glycemic control and reduced risk of complications.
Percentage of patients in each group with HbA1c <7.5%
HbA1c serves as a crucial physiological marker for assessing average blood sugar levels over the preceding three months. Values below 7.5 are deemed optimal for long-term health. Consequently, a higher number or percentage of individuals achieving an HbA1c level below 7.5 is indicative of a positive outcome, reflecting better glycemic control and reduced risk of complications.
CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L)
The CGM-measured percentage time 70-180 mg/dL (3.9-10.0 mmol/L) refers to the proportion of time during which an individual's blood glucose levels, as continuously monitored by a CGM device. This metric is crucial for assessing glycemic control in individuals with diabetes. Maintaining blood glucose within this target range is associated with better health outcomes and reduced risk of complications.
CGM-measured Percentage Time >180 mg/dL (>10.0 mmol/L)
Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.
Severe hypoglycemic episodes
Frequency of severe hypoglycemic episodes
Diabetes ketoacidosis
Frequency of diabetes ketoacidosis
Serious Adverse Events
Number, nature and severity of serious adverse events
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