T2 FSL2 Weight Loss

NCT05168306 | Terminated FDA Device

• 1 other identifier: ADC-US-RES-21215
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

FreeStyle Libre

Outcome Measures

Primary Outcomes (1)

• Difference in bodyweight from the control arm at 6 months

  Subjects' bodyweight will be measured during Visits 1, 3, 5 and 7. At the end of the 6 months period the bodyweight change, if any, will be assessed between the two Arms of the study.

  six (6) months

Study Arms (2)

Standard of Care

No intervention will be administered. Subjects randomized to the Standard of Care Arm will continue using their Current standard of care device to monitor and manage their diabetes

Intervention

Subjects randomized to this Arm will use FreeStyle Libre 2 to monitor and manage their diabetes.

Device: FreeStyle Libre 2 Flash Glucose Monitoring System

Interventions

FreeStyle Libre 2 Flash Glucose Monitoring System DEVICE

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.

Intervention

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been diagnosed with type 2 diabetes

You may qualify if:

• Subject must be at least 30 years of age and no more than 70 years of age at the time of enrollment.
• Subject must have laboratory-based HbA1c measurement of between 8.0% and 10.0%.
• Subject has 25% or more time spent above 180 mg/dL between the hours of 6am and 10pm during the screening phase.
• Subject has a Body Mass Index (BMI) of 30 or greater.
• Subject must have had a diagnosis of type 2 diabetes.
• Subject must be able to read and understand English and/or Spanish.
• In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• Subject is willing to make diet and lifestyle changes in response to education and glucose data
• Subject must be available to participate in all study visits.
• Subject must be willing and able to provide written signed and dated informed consent.

You may not qualify if:

• Subject is unable to perform mild physical activity (i.e. walking, stationary bike, etc.) for a minimum of 20 minutes per day.
• Subject has used an unblinded continuous glucose monitor in the three (3) months prior to enrollment.
• Subject is currently on any form of insulin therapy.
• Subject is currently on a low carbohydrate diet.
• Subject is currently using a commercial structured-meal weight loss program (i.e. Nutrisystem)
• Subject is currently taking sulfonylurea-based medications.
• Subject has experienced weight loss or gain of 5% or more of their total weight within the past 90 days.
• Subject is currently taking prescription weight loss drugs, including, but not limited to, bupropion-naltrexone (Contrave), liraglutide (Saxenda), orlistat (Xenical), phentermine-topiramate (Qsymia) and semaglutide (Wegovy).
• Subject is currently taking over-the-counter medications or supplements purported to aid in weight loss.
• Subject is currently taking intramuscular or intravenous corticosteroids.
• Subject has previously undergone or is planning on undergoing gastric bypass, gastric banding or gastric sleeve surgery in the next six (6) months.
• Subject is currently taking atypical antipsychotic medications.
• Subject has a condition that can lead to development of secondary diabetes (including but not limited to cystic fibrosis, hemochromatosis, chronic pancreatitis, polycystic ovary syndrome (PCOS), Cushing's syndrome, having undergone a pancreatectomy).
• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (1)

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara A Karinka, PhD

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 23, 2021
• Study Start: December 5, 2021
• Primary Completion: January 30, 2023
• Study Completion: July 19, 2023
• Last Updated: January 30, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)