Integração de Novas Competências na Educação em Diabetes com CGM (INSIDE-CGM)

Three-stage CGM integration program

Participants (and their consented care partner, if applicable) who are randomized to the intervention group will attend three closed group sessions over four weeks. Session 1 (Day 1) will be held in-person, where participants will receive technical training related to CGM sensor insertion, transmitter pairing, and receiver operation. Session 2 (Day 14) will be hybrid and will consist of training in how to read and understand CGM data, customize target ranges, alerts, and alarms, export and review historical data, and share CGM data with care partners. Session 3 (Day 28) will also be hybrid and will consist of training in strategies to utilize CGM for improved safety and quality of life. Between each session, participants will be remotely assessed for CGM use and glucose trends. Based on these remote assessments, participants may receive 1-2 additional individualized training sessions to review CGM technical skills, as well as data and self-management strategies associated with CGM use.

One-time clinic-based CGM training

Participants (and their consented care partner, if applicable) randomized to the one-time clinic-based CGM training group (Comparator A) will complete a one-hour visit with a clinic-based educator on Day 1 of the trial. This group will be provided with basic CGM training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period.

Self-directed CGM training

Participants randomized to the self-directed CGM training (Comparator B) will be provided with a comprehensive informational pamphlet about CGM on Day 1 of the trial. They will also be provided with a list of online resources for CGM self-training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period. Consented care partners will not be directly involved, as there is no session visit to attend.

CGM wear time will be calculated as the percentage of time that the sensor is in use and providing data, relative to the total time it could have been worn, with a total of 6-weeks of total possible wear during the active intervention period.

CGM use will be determined as a yes/no binary response as to whether the study participant is wearing a CGM at the 6-week endpoint of the study intervention.

The T1-DDAS will be administered to participants with Type 1 Diabetes. Self-reported core diabetes distress will be measured using the 30-item Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score. The scale yields a core score that is the average of all core questions (first 8 items) responses rated on a 5-point Likert scale for all 8 items, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher distress. A score >= 2.0 is considered clinically significant diabetes distress.

The T2-DDAS will be administered to participants with Type 2 Diabetes. Self-reported core diabetes distress will be measured using the 29-item Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score. The scale yields a core score that is the average of all core questions (first 8 items) responses rated on a 5-point Likert scale for all 8 items, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher distress. A score >= 2.0 is considered clinically significant diabetes distress.

The T1-DDAS will be administered to participants with Type 1 Diabetes. Self-reported sources of diabetes distress will be measured using the 30-item Type 1 Diabetes Distress Assessment System (T1-DDAS) source scale. Responses are rated on a 5-point Likert scale, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher impact that the source is likely to have in contributing to diabetes distress.

The T2-DDAS will be administered to participants with Type 2 Diabetes. Self-reported sources of diabetes distress will be measured using the 29-item Type 2 Diabetes Distress Assessment System (T2-DDAS) source scale. Responses are rated on a 5-point Likert scale, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher impact that the source is likely to have in contributing to diabetes distress.

Self-reported DQOL 15-item survey will be measured. Responses are rated on 5-point Likert scale. 7 questions ask about the frequency of negative impacts of diabetes or diabetes treatment and are scored from 1 (Never) to 5 (All the Time). 8 questions ask about satisfaction with treatment and quality of life and are scored from 1 (Very Satisfied) to 5 (Very Dissatisfied). Scoring is done by adding the numeric responses to the 15 questions, and can range from 15-75, with a higher score indicating a higher problem frequency or more dissatisfaction.

Self-reported SCI-R 15-item survey will be measured. Responses are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). For scoring, items are averaged and converted to a 0- to 100-point scale. Items that are not rated (or not applicable) are not included in the scoring. Higher scores indicate a better self-care.

The GMSS Type 1 Diabetes version will only be administered to participants with Type 1 Diabetes. Self-reported glucose monitoring system satisfaction will be measured using the 15-item questionnaire. Responses are rated on a 5-point Likert scale with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Scoring is done by calculating the mean score across responses. Certain items need to be reverse coded. A higher total score indicates greater satisfaction.

The GMSS Type 2 Diabetes version will only be administered to participants with Type 2 Diabetes. Self-reported glucose monitoring system satisfaction will be measured using the 15-item questionnaire. Responses are rated on a 5-point Likert scale with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Scoring is done by calculating the mean score across responses. Certain items need to be reverse coded. A higher total score indicates greater satisfaction.

Self-reported BenCGM 8-item survey will be measured. The scale yields a score based on the scale mean taken across all items using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher mean score indicates higher perceived benefit of continuous glucose monitor (CGM).

Self-reported BurCGM 8-item survey will be measured. The scale yields a score based on the scale mean taken across all items based on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher mean score indicates higher perceived barriers of continuous glucose monitor (CGM).

Investigator-written items will assess participant opinions and beliefs about using CGM technology, with Likert scale responses to statements ranging from 1 (strongly disagree) to 6 (strongly agree). Change across each item will be calculated at key intervention milestones and used to understand efficacy of the intervention, with higher scores equating to higher confidence in CGM use and application.

Investigator-written items to assess impact of CGM on sleep. Responses about sleep quality and impact will be ranked and assessed individually per item, with higher ranked responses indicating worsened impacts on sleep.

Investigator-written open-ended questions will explore impacts of participant CGM use on daily life. Responses will be thematically coded with standard qualitative data analysis methods.

Impact of CGM intervention on CGM satisfaction will be reported at endpoint after the intervention (week 6) and at month 3 and month 6 if participant is using personal CGM at month 3 and month 6. Self-reported CGM-SAT 44-item survey will be measured. Responses are on a 5-point Likert scale with responses ranges from 1 (agree strongly) to 5 (disagree strongly). After reverse scoring some items, the mean is calculated with higher mean scores reflecting greater satisfaction with CGM. This scale also includes two open-ended questions that will be evaluated using qualitative research methods.

Self-reported HFS-II W 18-item survey will be measured. The scale is a 5-point Likert scale with responses ranging from 0 (never) to 4 (almost always). A score of 3 or higher on any of the 18 items indicates fear of hypoglycemia. Higher average scores indicate higher fear of hypoglycemia.

Self-reported Clarke Score 8-item survey will be measured. Each answer correlates with a rating of A (aware) or R (reduced). 4 or more R responses suggest reduced hypoglycemia awareness. 3 responses suggest indeterminant hypoglycemia awareness. 2 or fewer R responses suggest hypoglycemia awareness.

Likert-type scale questions ranging from 1 (extremely unlikely) to 7 (extremely likely) for likelihood that each of the items would keep you from practicing regular physical activity during the next 6 months. Responses across 12-items are averaged, with lower average scores indicating a low level of perceived barriers to physical activity.

Participants will be contacted to self-administer two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)) per timepoint. Healthy Eating Index (HEI) scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating from a select list of healthy food categories. The scores range from 0 to 100. An ideal overall Healthy Eating Index score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).

Participants will be contacted to self-administer two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)) per timepoint. Carbohydrate intake (% of total kcal) will be calculated based on the recall responses averaged across both recalls delivered at each timepoint.

Participants will be contacted to self-administer two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Assessment Tool; ASA24) per timepoint. Protein intake (% of total kcal) will be calculated based on the recall responses averaged across both recalls delivered at each timepoint.

Participants will be contacted to self-administer two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Assessment Tool; ASA24) per timepoint. Fat intake (% of total kcal) will be calculated based on the recall responses averaged across both recalls delivered at each timepoint.

Self-reported General Self-Efficacy Scale (GSE) will be measured. Participants will be Likert-type scale questions ranging from Not at all true (1), Hardly true (2), Moderately true (3), Exactly true (4). The total score is calculated by finding the sum of all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay at baseline and Month 3.

When using the blinded continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point.

When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point.

When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point.

When using the blinded continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV) using 7-14 days of retrospective data at each time-point.

If participant is wearing a personal/unblinded CGM, data will be collected and assessed for change from baseline and endpoint (week 6). The percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point.

If participant is wearing a personal/unblinded CGM, data will be collected and assessed for change from baseline and endpoint (week 6). The percentage of sensor values in the hypoglycemic range (<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point.

If participant is wearing a personal/unblinded CGM, data will be collected and assessed for change from baseline and endpoint (week 6). The percentage of sensor values in the hyperglycemia range (>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point.

If participant is wearing a personal/unblinded CGM, data will be collected and assessed for change from baseline and endpoint (week 6). Glycemic variability will be assessed using the coefficient of variation (%CV) using 7-14 days of retrospective data at each time-point.

Investigator-written items will assess opinions and beliefs of care partners about participant's use of CGM technology, with Likert scale responses to statements ranging from 1 (strongly disagree) to 6 (strongly agree). Change across each item will be calculated at key intervention milestones and used to understand efficacy of the intervention, with higher scores equating to higher confidence in CGM use and application.

Investigator-written items to assess impact of participant CGM use on care partner's sleep. Responses about sleep quality and impact will be ranked and assessed individually per item, with higher ranked responses indicating worsened impacts on sleep.

Investigator-written open-ended questions will explore impacts of participant's CGM use on care partner's daily life. Responses will be thematically coded with standard qualitative data analysis methods.

Care partners of participants will be offered to complete the 21-item Partner Diabetes Distress (Partner DDS) questionnaire. The survey yields a mean score based on a 4-point Likert scale with responses ranging from 0 (not at all) to 4 (a great deal). Total score is calculated as the mean of the 21 items. Mean item score of 0-1.9 is considered little or no distress, between 2-2.9 is considered moderate distress, and >=3 is considered high distress.

Care partners of participants will be offered to complete the 12-item Partner Hypoglycemia Confidence Scale (Partner-HCS). The survey yields a mean score based on a 4-point Likert scale with responses ranging from 1 (not confident at all) to 4 (very confident). Total score is calculated as the mean of the 12 items. Higher mean score reflects higher partner hypoglycemia confidence and lower mean score reflects lower partner hypoglycemia confidence.

Care partners of participants will be offered to complete the 4-item DAWN Family Experience of Patient Involvement (DFEPI).

Two questions use a Likert scale with responses ranging from 1 (never) to 5 (always) to assess communication of support needs. Higher composite scores indicate a higher level of communication received about needs for support.

Two questions use a Likert scale with responses ranging from 1 (much less involved) to 5 (much more involved) to assess preferred level of involvement of family member. Higher composite scores indicate a care partner's higher desire for involvement in the participant's diabetes care.

Care partners of participants will be offered to complete the 7-item DAWN Impact of Diabetes Profile - Family Members (DIDP-FM). The survey yields a composite score based on a 7-point Likert scale with responses ranging from 1 (very negative impact) to 7 (very positive impact). N/A responses (8) are treated as missing. A composite scale score can be derived by taking the sum of items divided by the number of complete responses (i.e. not missing or N/A). Lower scale scores indicate greater negative impact and higher scale scores indicate greater positive impact of diabetes on a family member's life.