Change in HbA1c (%) from baseline between the intervention and control groups

Data were missing because the sample that was obtained from one patient could not be analyzed.

Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups

Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups

Change in number of prolonged hyperglycemia events (>90 minutes >300 mg/dL within a 120-minute period) per week from baseline, compared between the intervention and control groups

Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups

Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups

Change in number of CGM-measured hypoglycemia events per week (15 or more consecutive minutes <54 mg/dL) from baseline, compared between the intervention and control groups

Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups

Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups

Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups

Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups

Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups

Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups

Number of participants with HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks, compared between the intervention and control groups

Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups

CGM area over the curve (70 mg/dL), compared between the intervention and control groups

Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia, compared between the intervention and control groups. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.

Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups

CGM area under the curve (180 mg/dL), compared between the intervention and control groups

High Blood Glucose Index (HBGI) by CGM, compared between the intervention and control groups., as a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia.

Number of participants who achieved time in range 70-180 mg/dL >70%, compared between the intervention and control groups

Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%, compared between the intervention and control groups

Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%, compared between the intervention and control groups

Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups

Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups

Number of participants with time in range 70-180 mg/dL >70% and time <54 mg/dL <1%, compared between the intervention and control groups

Total daily insulin delivery (units), compared between the intervention and control groups

Percentage of insulin delivered as basal, compared between the intervention and control groups

Change in weight (kg) from baseline, compared between the intervention and control groups

Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

Change in triglycerides (mg/dL), compared between the intervention and control groups

Patient-reported outcome (PRO) measures from the Type 2 Diabetes Distress Assessment System (Core and Source) questionnaire, compared between the intervention and control groups. The T2-DDAS includes a Core measure that precisely characterizes the intensity of the emotional DD experience, and a set of Sources measures that identifies the key contributors or specific sources of distress. The seven Sources are: management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma and healthcare access. Scoring for each question is on a scale of 1-5, with higher scores indicating more problems/distress. Scores are reported individually per domain area at baseline and 13 weeks.

Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups. The DIDP provides a brief assessment of the perceived impact of diabetes on six key dimensions of life. Participants rate the impact of diabetes on each domain on a 7-point scale, with 1 being a very positive impact and 7 being a very negative impact. A converted percentage (0-100%) scale scores are reported. Lower scale scores indicate greater positive impact and higher scale scores indicate greater negative impact across global life dimensions.

Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups. For the DIDS satisfaction score, scores range from 0-10 with higher scores indicating better outcome. For the DIDS impact score, scores range from 0-10 with lower scores indicating better outcome.

Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups. The PROMIS Sleep-Related Impairment Questionnaire utilizes a T-score metric for scoring, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater sleep-related impairment. The questionnaire uses a 5-point Likert scale (1=never to 5=always) for each item, and the responses are summed to calculate a total raw score. This raw score is then converted to a T-score using a lookup table provided in the scoring manual.

Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups. 10 items rated on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). Total score is on a 100 point scale (0 - 100), with higher scores indicating greater usability.

Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II Behavior and Worry Scores, compared between the intervention and control groups. The HFS-II consists of 33 items, which are organized into two subscales: HFS-B (Behavior): A 15 item subscale that focuses on behaviors to avoid hypoglycemia, and HFS-W (Worry): a 18 item subscale that focuses on worries about hypoglycemia and its consequences. The HFS-II subscale scores range from 0-60 and 0-72 for the HFS-B and HFS-W, respectively. Higher scores indicate higher fear of hypoglycemia.

Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups, showing EQ-Index Scores. The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories, from which a single EQ-5D index score can be calculated ranging from 0 (worst imaginable health) to 1 (best imaginable health) on which participants have to indicate their current health.