Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- CGM Wear Time
研究概览
简要总结
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 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) 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. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.
Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.
详细描述
This study will assess the preliminary effectiveness of a continuous glucose monitor (CGM) integration program ("intervention") in a 6-week randomized pilot study among 144 older adults with diabetes using insulin at least once daily. The CGM integration program (48 participants) will be compared to two versions of usual care: 1) one-time clinic-based CGM training (Comparator 1; 48 participants) and 2) self-directed CGM training (Comparator 2; 48 participants). 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 6-week supply 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 1) 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 2) 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 continuous wear-time. In addition, secondary patient-reported outcomes and glycemic metrics will be assessed, including use of the CGM device at 6 weeks. We will conduct semi-structured interviews with a subset of purposively sampled participants (up to 20) and their care partners (up to 10) 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.
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The interventionist, project manager, and data manager will be unblinded to participant treatment assignment to permit proper intervention delivery and study operations. The PI, clinical collaborators, and the study statistician will be blinded to allocation for the duration of the trial.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Inclusion Criteria:
- •Adults 65 years and older at time of consent
- •Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.
- •Using any insulin at least once daily
- •No continuous glucose monitor (CGM) use within the previous 365 days
- •Willing to use a smartphone to access glucose readings using CGM phone app
- •Fluent in English
- •Participant
排除标准
- •Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
- •Currently receiving dialysis, assessed through chart review and self-report on screening visit
- •Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit
- •The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year, assessed at screening visit
- •Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures
- •Not fluent in English
- •Unable to consent to recording of sessions
- •Care Partner Inclusion Criteria:
- •Live in the same household as the study participant
- •Age 18 years or older
- •Fluent in English
- •Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes
- •Consent to recording of sessions
研究组 & 干预措施
Intervention
Three-stage CGM integration program
干预措施: Three-stage CGM integration program (Behavioral)
Comparator A
One-time clinic-based CGM training
干预措施: One-time clinic-based CGM training (Behavioral)
Comparator B
Self-directed CGM training
干预措施: Self-directed CGM training (Behavioral)
结局指标
主要结局
CGM Wear Time
时间窗: Over 6 Weeks
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 Wear Time
时间窗: Week 6
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 at 6 Weeks
时间窗: Week 6
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.
次要结局
- Change in Self Care Inventory-Revised Version (SCI-R) Score(Baseline, Week 6)
- Change in Impact of Diabetes Quality of Life-Brief Clinical Inventory (DQOL) Score(Baseline, Week 6, Month 3, Month 6)
- Change in DAWN Family Experience of Patient Involvement (DFEPI) Score(Baseline, Week 6, Month 3, Month 6)
- Change in DAWN Impact of Diabetes Profile - Family Members (DIDP-FM) Score(Baseline, Week 6, Month 3, Month 6)
- CGM Use at 6 Weeks(Week 6)
- Change in Impact of Diabetes Profile (DIDP 7-item) Score(Baseline, Week 6, Month 3, Month 6)
- Change in Core Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score(Baseline, Week 6, Month 3, Month 6)
- Change in Hemoglobin A1c (HbA1c)(Baseline, Month 3)
- Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score(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(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(Baseline, Week 6, Month 3, Month 6)
- Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 1 Diabetes version Score(Baseline, Week 6)
- Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 2 Diabetes version Score(Baseline, Week 6)
- Change in Benefits of CGM (BenCGM) Score(Baseline, Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in Burdens of CGM (BurCGM) Score(Baseline, Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in Opinions and Beliefs about CGM Technology [Investigator-written](Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in sleep quality affected by CGM [Investigator-written](Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in quality of life affected by CGM [Investigator-written](Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in General Self-Efficacy Scale (GSE) Score(Baseline, Week 6)
- Change in Percentage of Time in Range (TIR)(Baseline, Week 6)
- Change in CGM satisfaction (CGM-SAT) Score(Week 6, Month 3, Month 6)
- Change in Hypoglycemia Fear (Hypoglycemia Fear Survey; Worry Subscale, HFS-II W) Score(Baseline, Week 6)
- Change in Clarke Score (Hypoglycemia Unawareness)(Baseline, Week 6)
- Change in Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Score(Baseline, Week 6)
- Change in Healthy Eating Index (HEI) Score based on average intake across two 24-hour recalls(Baseline, Week 6)
- Change in carbohydrate intake based on average intake across two 24-hour recalls(Baseline, Week 6)
- Change in protein intake based on average intake across two 24-hour recalls(Baseline, Week 6)
- Change in fat intake based on average intake across two 24-hour recalls(Baseline, Week 6)
- Change in Percentage of Time Below Range (TBR)(Baseline, Week 6)
- Change in Percentage of Time Above Range (TAR)(Baseline, Week 6)
- Change in Percentage of Glycemic Variability(Baseline, Week 6)
- Change in Percentage of Time in Range (TIR)(Month 3, Month 6)
- Change in Percentage of Time Below Range (TBR)(Month 3, Month 6)
- Change in Percentage of Time Above Range (TAR)(Month 3, Month 6)
- Change in Percentage of Glycemic Variability(Month 3, Month 6)
- Change in care partner Opinions and Beliefs about CGM Technology [Investigator-written](Baseline, Week 6, Month 3, Month 6)
- Change in care partner sleep quality affected by CGM [Investigator-written](Baseline, Week 6, Month 3, Month 6)
- Change in care partner quality of life affected by CGM [Investigator-written](Baseline, Week 6, Month 3, Month 6)
- Change in Care Partner Diabetes Distress (Partner DDS) Score(Baseline, Week 6, Month 3, Month 6)
- Change in Care Partner Hypoglycemia Confidence Scale (Partner-HCS) Score(Baseline, Week 6, Month 3, Month 6)