This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. Lastly, an extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.
This study will assess the preliminary effectiveness of a continuous glucose monitor (CGM) integration program ("intervention") in a 6-week randomized pilot study among 150 older adults with diabetes using insulin. The CGM integration program will be compared to two versions of usual care: 1) one-time clinic-based CGM training (Comparator A) and 2) self-directed CGM training (Comparator B). Following a screening visit and baseline data collection, participants will be randomized to one of the three groups in a 1:1:1 ratio by computer-generated sequence. All participants will be provided with 60-days of unblinded CGM sensors. Participants who are randomized to the intervention group will attend three closed group sessions over 4 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 held virtually 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 held virtually 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. Participants 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. 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. At the end of the 6-week trial, all participants will provide primary endpoint data related to wear-time and use of the CGM device. In addition, secondary patient-reported outcomes and glycemic metrics will be assessed. We will conduct semi-structured interviews with a subset of purposively sampled participants and their care partners (N=50) after their final endpoint visit to probe effective aspects of the intervention, challenges, struggles, and needs that were not addressed by the intervention, and strategies to improve the accessibility, acceptability, and effectiveness of the intervention for future older adults. Lastly, we will conduct an extension study in which we evaluate the following metrics at 3- and 6-months post-intervention: 1) CGM prescribing patterns post-study, including the proportion of participants with a CGM order at 3 and 6 months after study endpoint; 2) Clinical and patient-reported outcomes, such as glycemic indicators, severe hypoglycemia, device satisfaction (if applicable), barriers to sustained CGM access, integration of CGM into care and self-management, and unmet needs; 3) provider documentation of clinical rationale, perceived benefits, and barriers to CGM use across diverse care settings (internal medicine, family medicine, geriatrics, endocrinology).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Participants 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.
Participants 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.
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
CGM Wear Time
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.
Time frame: Week 6
CGM Use at 6 Weeks
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.
Time frame: Week 6
Change in Core Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Sources of Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Source Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Sources of Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Source Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Impact of Diabetes Profile (DIDP 7-item) Score
Self-reported DIDP 7-item survey will be measured. Responses are rated on a 7-point Likert scale ranging from 1 (very positive impact) to 7 (very negative impact). 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 positive impact and higher scale scores indicate greater negative impact across global life dimensions.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Self Care Inventory-Revised Version (SCI-R) Score
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). Scoring guidelines for type 1 and type 2 diabetes will be followed, with three items omitted from the score for type 2 diabetes. Scored items are averaged and converted to a 100-point scale, with higher scores indicating high levels of self-care.
Time frame: Baseline, Week 6
Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 1 Diabetes version Score
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.
Time frame: Baseline, Week 6
Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 2 Diabetes version Score
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.
Time frame: Baseline, Week 6
Change in Benefits of CGM (BenCGM) Score
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).
Time frame: Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
Change in Burdens of CGM (BurCGM) Score
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).
Time frame: Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
Change in Opinions and Beliefs about CGM Technology [Investigator-written]
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.
Time frame: Week 2, Week 4, Week 6, Month 3, Month 6
Change in sleep quality affected by CGM [Investigator-written]
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.
Time frame: Week 2, Week 4, Week 6, Month 3, Month 6
Change in quality of life affected by CGM [Investigator-written]
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.
Time frame: Week 2, Week 4, Week 6, Month 3, Month 6
Change in CGM satisfaction (CGM-SAT) Score
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.
Time frame: Week 6, Month 3, Month 6
Change in Hypoglycemia Fear (Hypoglycemia Fear Survey; Worry Subscale, HFS-II W) Score
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.
Time frame: Baseline, Week 6
Change in Clarke Score (Hypoglycemia Unawareness)
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.
Time frame: Baseline, Week 6
Change in Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Score
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.
Time frame: Baseline, Week 6
Change in Healthy Eating Index (HEI) Score based on average intake across two 24-hour recalls
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).
Time frame: Baseline, Week 6
Change in carbohydrate intake based on average intake across two 24-hour recalls
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.
Time frame: Baseline, Week 6
Change in protein intake based on average intake across two 24-hour recalls
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.
Time frame: Baseline, Week 6
Change in fat intake based on average intake across two 24-hour recalls
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.
Time frame: Baseline, Week 6
Change in General Self-Efficacy Scale (GSE) Score
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.
Time frame: Baseline, Week 6
Change in Hemoglobin A1c (HbA1c)
HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay at baseline and Month 3.
Time frame: Baseline, Month 3
Change in Percentage of Time in Range (TIR)
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.
Time frame: Baseline, Week 6
Change in Percentage of Time Below Range (TBR)
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.
Time frame: Baseline, Week 6
Change in Percentage of Time Above Range (TAR)
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.
Time frame: Baseline, Week 6
Change in Percentage of Glycemic Variability
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.
Time frame: Baseline, Week 6
Change in Percentage of Time in Range (TIR)
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.
Time frame: Month 3, Month 6
Change in Percentage of Time Below Range (TBR)
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.
Time frame: Month 3, Month 6
Change in Percentage of Time Above Range (TAR)
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.
Time frame: Month 3, Month 6
Change in Percentage of Glycemic Variability
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.
Time frame: Month 3, Month 6
Change in care partner Opinions and Beliefs about CGM Technology [Investigator-written]
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in care partner sleep quality affected by CGM [Investigator-written]
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in care partner quality of life affected by CGM [Investigator-written]
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Care Partner Diabetes Distress (Partner DDS) Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
Change in Care Partner Hypoglycemia Confidence Scale (Partner-HCS) Score
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.
Time frame: Baseline, Week 6, Month 3, Month 6
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