NCT07463209Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 5.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 144 (tervezett)
- Első benyújtás
- 2026. márc. 4.
- Kezdés
- 2026. aug. 11.
- Elsődleges befejezés
- 2028. márc.
- Fő szponzor
- University of North Carolina, Chapel Hill
- NCT-szám
- NCT07463209
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 144
- 2026. aug. 11. és az elsődleges befejezés (2028. márc.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- 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
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | Egyesült Államok | Toboroz |
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