Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM)

May 26, 2026 updated by: University of North Carolina, Chapel Hill

Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes

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. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. The CGM integration program (48 participants) will be compared to two versions of usual care: 1) one-time clinic-based CGM training (Comparator A; 48 participants) and 2) self-directed CGM training (Comparator B; 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 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 (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).

Lastly, this study will involve a care partner sub-study. The aim of the care partner sub-study is to understand how the intervention improves or changes the knowledge and attitudes around CGM and diabetes management in care partners of older adults with diabetes. Consented care partners will be invited to attend any session their partner participant is assigned to. Care partners will be asked to complete care partner-specific questionnaires at baseline, at the end of the 6-week trial, and at 3- and 6-months post-intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marcy Menard, MS, RD, LDN, CDCES
  • Phone Number: 919-843-9977
  • Email: mmenard@unc.edu

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
        • Contact:
          • Marcy Menard, MS, RD, LDN, CDCES
          • Phone Number: 919-843-9977
          • Email: mmenard@unc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 residing within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.
  • Using any insulin
  • 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 Exclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Three-stage CGM integration program
Behavioral: 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.
Active Comparator: Comparator A
One-time clinic-based CGM training
Behavioral: 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.
Active Comparator: Comparator B
Self-directed CGM training
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CGM Wear Time
Time Frame: 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.
Week 6
CGM Use at 6 Weeks
Time Frame: 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.
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Core Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
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
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
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
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Impact of Diabetes Profile (DIDP 7-item) Score
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 1 Diabetes version Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Glucose Monitoring System Satisfaction Survey (GMSS) Type 2 Diabetes version Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Benefits of CGM (BenCGM) Score
Time Frame: Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
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).
Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
Change in Burdens of CGM (BurCGM) Score
Time Frame: Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
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).
Baseline, Week 2, Week 4, Week 6, Month 3, Month 6
Change in Opinions and Beliefs about CGM Technology [Investigator-written]
Time Frame: Week 2, Week 4, Week 6, Month 3, Month 6
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.
Week 2, Week 4, Week 6, Month 3, Month 6
Change in sleep quality affected by CGM [Investigator-written]
Time Frame: Week 2, Week 4, Week 6, Month 3, Month 6
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.
Week 2, Week 4, Week 6, Month 3, Month 6
Change in quality of life affected by CGM [Investigator-written]
Time Frame: Week 2, Week 4, Week 6, Month 3, Month 6
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.
Week 2, Week 4, Week 6, Month 3, Month 6
Change in CGM satisfaction (CGM-SAT) Score
Time Frame: Week 6, Month 3, Month 6
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.
Week 6, Month 3, Month 6
Change in Hypoglycemia Fear (Hypoglycemia Fear Survey; Worry Subscale, HFS-II W) Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Clarke Score (Hypoglycemia Unawareness)
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Healthy Eating Index (HEI) Score based on average intake across two 24-hour recalls
Time Frame: Baseline, Week 6
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).
Baseline, Week 6
Change in carbohydrate intake based on average intake across two 24-hour recalls
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in protein intake based on average intake across two 24-hour recalls
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in fat intake based on average intake across two 24-hour recalls
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in General Self-Efficacy Scale (GSE) Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Month 3
HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay at baseline and Month 3.
Baseline, Month 3
Change in Percentage of Time in Range (TIR)
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Percentage of Time Below Range (TBR)
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Percentage of Time Above Range (TAR)
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Percentage of Glycemic Variability
Time Frame: Baseline, Week 6
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.
Baseline, Week 6
Change in Percentage of Time in Range (TIR)
Time Frame: Month 3, Month 6
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.
Month 3, Month 6
Change in Percentage of Time Below Range (TBR)
Time Frame: Month 3, Month 6
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.
Month 3, Month 6
Change in Percentage of Time Above Range (TAR)
Time Frame: Month 3, Month 6
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.
Month 3, Month 6
Change in Percentage of Glycemic Variability
Time Frame: Month 3, Month 6
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.
Month 3, Month 6
Change in care partner Opinions and Beliefs about CGM Technology [Investigator-written]
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in care partner sleep quality affected by CGM [Investigator-written]
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in care partner quality of life affected by CGM [Investigator-written]
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Care Partner Diabetes Distress (Partner DDS) Score
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Care Partner Hypoglycemia Confidence Scale (Partner-HCS) Score
Time Frame: Baseline, Week 6, Month 3, Month 6
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.
Baseline, Week 6, Month 3, Month 6
Change in Self Care Inventory-Revised Version (SCI-R) Score
Time Frame: Baseline, Week 6
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.
Baseline, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Diabetes Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Kahkoska, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-2713
  • 7-25-ICTSAD-414 (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 6 to 18 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Beginning 6 and continuing for 18 months following publication

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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