Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2

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.

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.

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.

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.

Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.

CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome.

Blood sugar values measured by CGM that fall below 70 mg/dL are considered potentially hazardous, as they may lead to unconsciousness and, in severe cases, even death. Therefore, minimizing the time spent below 70 mg/dL is regarded as a highly positive outcome, reflecting better management of low blood sugar episodes and enhanced safety for the individual.

Blood sugar values measured by CGM that fall below 60 mg/dL are considered potentially hazardous, as they may lead to unconsciousness and, in severe cases, even death. Therefore, minimizing the time spent below 60 mg/dL is regarded as a highly positive outcome, reflecting better management of low blood sugar episodes and enhanced safety for the individual.

Standard Deviation represents how much glucose levels fluctuate over time from a given average.

The Coefficient of Variability (CV) is calculated as the ratio of the standard deviation to the mean of blood sugar values for each participant, as measured by CGM. The reported CV value is derived by multiplying the ratio of the standard deviation to the mean by 100, providing a percentage that reflects the degree of variability in blood sugar levels across the population. A higher CV value, which can range up to 100, signifies greater dispersion of CGM values, indicating more significant fluctuations in blood sugar levels. This increased variability is generally considered an unfavorable outcome, as it may suggest less stable glucose control. Conversely, the minimum CV value is 0, which would indicate no variability in blood sugar levels, representing perfect stability.

The CGM-Measured Glucose Risk Index (GRI) is a comprehensive metric derived from CGM data, designed to quantify the overall risk associated with blood glucose variability. It integrates multiple aspects of glucose levels, including the frequency and severity of both hypo- and hyperglycemic events, as well as the duration of time spent outside the target glucose range. A lower GRI score indicates better glucose stability and lower risk of adverse outcomes related to blood sugar fluctuations.

The Self-Management of Type 1 Diabetes for Chinese Adults (SMOD-CA) scale is a validated instrument specifically designed to assess the self-management behaviors and capabilities of adults with type 1 diabetes in the Chinese population. The SMOD-CA consists of 30 items. Responses are rated on a five-point scale, with higher scores indicating better self-management ability. The total score ranges from 0 to 120.

The 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents (C-SMOD-A-23) is a validated and simplified instrument designed to assess the self-management behaviors and capabilities of adolescents with type 1 diabetes.

Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire comprising seven component scores (subjective sleep quality, sleep latency, duration of sleep, sleep efficiency habits, sleep disturbances, use of sleeping medication, and daytime dysfunction), is used to evaluate sleep quality over the last month.

The Hypoglycemic Fear Scale is a widely used and validated assessment tool designed to measure the level of fear and anxiety that individuals with diabetes, particularly those with type 1 diabetes, experience in relation to hypoglycemia (low blood sugar).

The Diabetes Technology Attitude Scale is a specialized assessment tool designed to evaluate individuals' attitudes toward diabetes-related technologies.

Tool lists statement and participants reports how much they agree with the statement.

The Barriers to Technology Questionnaire typically consists of several key sections, each designed to capture different aspects of technology adoption and use.

The Diabetes Treatment Satisfaction Questionnaire (DTSQ) is a comprehensive and widely utilized tool designed to assess the level of satisfaction that individuals with diabetes have with their current treatment regimens. The DTSQ is usually administered as a self-report questionnaire, allowing patients to rate their responses on a Likert scale, typically ranging from "very dissatisfied" to "very satisfied." The total score is calculated by summing the responses to all relevant items, with higher scores indicating greater satisfaction with the treatment.

The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression.

The Depression Self-Rating Scale for Children (DSRSC) is a standardized psychological assessment tool designed to measure depressive symptoms in children and adolescents. This self-report inventory allows young individuals to rate the frequency and severity of various depressive feelings and behaviors they may be experiencing.

The Generalized Anxiety Disorder 7-item scale (GAD-7) consists of seven items. Each item asks respondents to rate how often they have been bothered by specific anxiety-related symptoms over the past two weeks.

The WHO-5 Well-Being Index (WHO-5) is a brief, self-report questionnaire designed to assess subjective well-being. The WHO-5 consists of five simple and straightforward items. Each item is rated on a 6-point Likert scale, ranging from 0 (not present) to 5 (constantly present). The total score is calculated by summing the responses to all five items, resulting in a score that ranges from 0 to 25. Higher scores indicate better well-being.

Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness).

The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia.

Frequency of severe hypoglycemic episodes

Frequency of diabetes ketoacidosis

Number, nature and severity of serious adverse events