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Integrating New Skills Into Diabetes Education With CGM

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks, 4 weeks
  • Procedures mentioned: Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
  • "Participants who are randomized to the intervention group will attend three closed group sessions over 4 weeks."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a three-step training program for using a continuous glucose monitor (CGM), a device that tracks blood sugar. It is for adults age 65 or older who take insulin daily and have not used a CGM in the past year. The study compares this program with two standard training options to see how they affect CGM use, blood sugar, and participants’ experiences.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 65 or older.
  • Have had at least 2 visits in the past year at a UNC Health or UNC Physicians Network clinic for primary care, family medicine, internal medicine, older adult care, or hormone care. The clinic must be within 90 miles of UNC Main Hospital in Chapel Hill, NC.
  • Use insulin at least once a day.
  • Have not used a CGM in the past year.
  • Be willing to use a smartphone app to view blood sugar readings, or a loaner phone or receiver if your phone does not work with the app.
  • Speak English fluently.
  • For the optional care partner study: be age 18 or older, live with the participant, and speak English fluently.
  • Care partners must agree to attend sessions with the participant, learn how to help with diabetes care, and have sessions recorded.

Who can't join

  • Have dementia, a condition that affects memory and thinking. Mild thinking or memory problems without dementia are allowed.
  • Receive dialysis, a treatment that filters blood when the kidneys cannot.
  • Have severe vision or hearing problems that prevent CGM use or taking part in group sessions in person or online.
  • Have a major physical or mental health condition, or take a medicine, that the study doctor thinks could prevent study completion or mean you may live less than 1 year.
  • Cannot take part for the full 6 weeks or are unwilling to follow study steps.
  • Do not speak English fluently.
  • Cannot agree to have sessions recorded.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Willing to use a loaner smartphone or receiver if personal smartphone is not compatible with 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 * 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

Study sites (1)

NC