Запуск технологии в исследовании диабета 1 типа, находящегося в группе риска (STAR-T1D)

Participants will meet 1:1 with our CDE for at least 6 sessions over 6 weeks. Sessions will cover self-management basics, carb counting, CGM interpretation, hypoglycemia and hyperglycemia management and troubleshooting device issues. The investigators will follow up with participants in 24 and 72 hours after CGM and insulin pump initiation, respectively, to answer any device related questions that may arise in between sessions.

Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects and evaluate device and safety issues associated with pump settings in the HCL arm. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.

Patients will be started on an automated insulin delivery system.

Participants in the control arm will receive diabetes education at a similar frequency as the intervention group. Diabetes education for the control group will be a combination of in-person visits with the CDE and telephone brief diabetes education sessions.

Participants will follow up at intervals of 1-4 weeks throughout the study. During visits, the investigators will assess for adherence and adverse effects. The investigators will repeat A1c at 12 weeks and 24 weeks and administer follow up questionnaires at 12 and 24 weeks.

Eligible among screened, enrolled among eligible, excluded among screened (and why) based on screening, recruitment and enrollment data.

Randomized among enrolled, and receiving allocated intervention among randomized.

Average time delay from screening to enrollment.

Retention among participants receiving allocated intervention after being randomized and discontinued intervention among randomized.

Participants lost to follow-up among those initially randomized.

Retention rates by participants completing all research assessments among randomized.

Treatment-specific adherence, Adherence to study protocol and Proportion of planned assessments that are completed.

Fidelity, which pertains to guaranteeing that the intervention is delivered in accordance with the established protocol, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate.

Adherence, which relates to the extent to which participants follow the treatment and study protocol, as well as the proportion of planned assessments completed, will be summarized by study arms, and differences between arms will be examined using t-tests or two-sample tests of proportions as appropriate.

Serum Hemoglobin A1c laboratory measurement

Hypoglycemia will be measure by combining CGM metrics and glucometer to report severe hypoglycemia in mg/dl.

Assess instances of diabetic ketoacidosis through participant surveys and comprehensive chart reviews.

Number of diabetes related ED visits or hospitalizations

Assessing treatment burden through the Type 1 Diabetes Distress Assessment System T1DDAS, which comprises eight questions and evaluates ten prevalent sources of diabetes distress in adults with type 1 diabetes. The score indicates the level of diabetes distress reported by the respondent, with higher scores indicating greater intensity. The core scale scoring ranges 1 to 5. This scale assesses each of ten common Sources of diabetes distress for adults with type 1 diabetes: Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack Of Diabetes Resources, Technology Challenges, Burden To Others, Worries About Complications. The higher the score, the more impactful that Source is likely to be in contributing to diabetes distress for this individual with the minimum value being 1 and maximum value being 5.

Assessed treatment burden and satisfaction using the Insulin Treatment Satisfaction Questionnaire (ITSQ), consisting of 22 questions among 5 content clusters with a score from 0 to 100% where a higher score indicates greater satisfaction with insulin treatment. The scale explores perceptions of current insulin treatment and its impact on daily life.

Examined treatment burden and satisfaction employing the Glucose Monitoring System Satisfaction Survey (GMSS), comprising 15 questions divided into four subcategories: openness, emotional burden, behavioral burden and trust. Higher scores within each subcategory denote either greater satisfaction or burden, depending on the specific aspect assessed with the minimum value being 1 and maximum value being 5. The total scare has a minimum value of 1 and maximum value of 15 with higher scores indicating greater satisfaction. The scores are obtained by calculating the mean for each.

Assessed treatment burden and satisfaction using the Motivation and Attitudes towards Health Scale (MATCH), consisting of nine questions categorized into four subgroups: willingness to make changes, perceived ability to make or maintain changes, feeling changes are worthwhile, and overall mean/average of willingness, able, and worthwhile. Scores are calculated by determining the mean or average response within each category with higher scores meaning a better outcome.

WILLINGNESS: minimum value is 1 and maximum value is 5. ABLE: minimum value is 1 and maximum value is 5. WORTHWHILE: minimum value is 1 and maximum value is 5. TOTAL SCALE: minimum value is 1 and maximum value is 9.