Clinical Trials Logo

Clinical Trial Summary

The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM). The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.


Clinical Trial Description

This will be a prospective, single-center, pre-post pilot study where enrolled participants will be given free FreeStyle Libre 2 sensors for 3 months and will be followed by pharmacists in the Upstate Adult Medicine Clinic. During the first visit, pharmacists will order a baseline hemoglobin A1c, confirm the participant's current medication list, provide CGM education and assess patient's willingness to scan. Participants will also be asked to participate in a voluntary initial satisfaction survey (Glucose Monitoring Satisfaction Survey). Sensors will be placed at the end of the first visit. No medication changes will be made in order to obtain baseline data for each participant. All initial visits will be conducted in-office. Baseline characteristics will be collected at this visit. The second visit will be scheduled approximately 2 weeks after the initial visit and will also be in-office. Since no medication changes were made during the first visit, the second visit will provide baseline CGM data, which will be reviewed with the participant. All subsequent follow-up visits will be scheduled at 2-week intervals unless an earlier visit is determined to be necessary by the pharmacist. At the discretion of the pharmacists, subsequent follow-up visits can either be a telemedicine encounter or an in-office visit. CGM data and medication changes will be documented at each visit. The final visit will be scheduled approximately 3 months after sensor placement and will be in-office. Participants will be asked to participate in the post satisfaction survey (Glucose Monitoring Satisfaction Survey). Pharmacists will repeat the hemoglobin A1c, review the final medication list, remove the sensors, and review plan for self-monitoring blood glucose with patient moving forward. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05200390
Study type Interventional
Source State University of New York - Upstate Medical University
Contact
Status Enrolling by invitation
Phase N/A
Start date January 24, 2022
Completion date February 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Recruiting NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Recruiting NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Enrolling by invitation NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Not yet recruiting NCT05127291 - Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus N/A
Recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Not yet recruiting NCT05492448 - Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease N/A
Recruiting NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Active, not recruiting NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A
Completed NCT04053959 - Artificial Intelligence Assisted Insulin Titration System Phase 4
Recruiting NCT03130244 - Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes N/A
Recruiting NCT05516797 - IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE) N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Not yet recruiting NCT04822740 - Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU N/A