NCT07128342Toborzás még nem indult
CGM Use in Non-insulin Patients With DM2
Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 18. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes who want to better understand how diet and exercise may impact blood sugar levels. However robust evidence supporting that CGM is significantly superior to traditional home fingerstick blood glucose monitoring (FSBGM) in this population is lacking. Thus, Medicare and VHA only authorize use of CGM for patients with diabetes who require daily insulin therapy , unless they meet special criteria such as having hypoglycemia or inability to monitor glucose via traditional FSBGM. Objectives Primary Study Aim: Among veterans with uncontrolled diabetes not requiring insulin therapy who are participating in an intensive multidisciplinary program to improve diabetes control (VDOP), to assess whether use of a CGM compared to use of traditional FSBGM results in greater change in hemoglobin A1c upon VDOP completion and up to 12 months. Secondary study aims: To assess whether use of CGM in this population leads to greater improvement in diet, physical activity, and weight loss upon VDOP completion and up to 12 months. Hypothesis The use of a CGM by Veterans with T2DM who do not use insulin will help them improve their diabetes self - management (diet, physical activity, weight) and glycemic control more so than those using traditional fingerstick glucose monitoring. Methods This will be a prospective "open label" randomized controlled trial where participants will be randomly assigned to CGM (intervention group) or FSBGM (control group) during their participation in VDOP. Relevance to Veterans and VA mission Most Veterans with T2DM do not use insulin. It is important for both, these Veterans and the VA, to learn whether this more costly and somewhat burdensome technology supports improvement in diabetes self-management
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2025. aug. 12.
- Kezdés
- 2025. nov. 1.
- Elsődleges befejezés
- 2027. nov.
- Fő szponzor
- Milwaukee VA Medical Center
- NCT-szám
- NCT07128342
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 100
- 2025. nov. 1. és az elsődleges befejezés (2027. nov.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
Más betegség
- Patients with gestational diabetes or pregnant at time of screening or are planning to become pregnant during the study
- Patients with end stage renal disease (ESRD) on dialysis
- Known or suspected significant allergy to use the Dexcom sensors
Laborértékek
- Acute conditions that impact the HbA1c measurement stability such as GI blood loss, recent (within 3 months of study entry), anticipated red blood cell transfusion or erythropoietin administration
Egyéb
- Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
- Planning or currently enrolled on different weight program different from MOVE!
- Participating other clinical trials
Kiket keres a vizsgálat
- Successfully enrolled and ready to begin the VDOP program not on insulin therapy
- Type 2 diabetes by clinical history
- HbA1C between 8.0-12.0% inclusive within 3 months of enrollment
- Assessment by clinician that patient is willing to and able to wear a CGM device
- Stable diabetes medication regimen during the 3 months prior to entry
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.