Back to resultsT2 FSL2 Weight Loss
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreeStyle Libre 2 Flash Glucose Monitoring System
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring FreeStyle Libre
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject is currently undergoing or is anticipated to undergo treatment for cancer (including but not limited to oral and/or intravenous chemotherapy, radiation treatment, surgery, bone marrow transplant).
- Subject has untreated mental illness and/or opiate addiction.
- Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
- Subject is currently undergoing dialysis and/or has end stage renal disease.
- Subject is currently participating in another interventional clinical trial.
- Subject is unsuitable for participation due to any other cause as determined by the investigator.
Sites / Locations
- Rainier Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Intervention
Arm Description
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
Subjects randomized to this Arm will use FreeStyle Libre 2 to monitor and manage their diabetes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05168306
Brief Title
T2 FSL2 Weight Loss
Official Title
Evaluation of the Impact of the FreeStyle Libre 2 Flash Glucose Monitoring System, Compared to the Current Standard of Care (SOC), on Weight Reduction in Subjects With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diabetes Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a non-pivotal, randomized, two-arm, multi-center, prospective, non-significant risk study to evaluate the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System compared to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
Subjects who have been diagnosed with type 2 diabetes will be randomized to use FreeStyle Libre 2 sensor (intervention arm) or their current standard of care (control arm) to manage their diabetes for a period of 6 months. Subjects will be asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline (visit 1) and during visit 6. Subjects will also complete a separate subject questionnaire during visit 6.
All subjects will wear a FreeStyle Libre Pro sensor for enrollment (Screening) purposes and to collect baseline glycemic data prior to randomization. In addition, all subjects in both the intervention and control arms will wear an FSL Pro at days 75 and 165 for collection of glycemic endpoint data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
FreeStyle Libre
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Subjects randomized to this Arm will use FreeStyle Libre 2 to monitor and manage their diabetes.
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre 2 Flash Glucose Monitoring System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in bodyweight from the control arm at 6 months
Description
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.
Time Frame
six (6) months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
Subject is currently undergoing or is anticipated to undergo treatment for cancer (including but not limited to oral and/or intravenous chemotherapy, radiation treatment, surgery, bone marrow transplant).
Subject has untreated mental illness and/or opiate addiction.
Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
Subject is currently undergoing dialysis and/or has end stage renal disease.
Subject is currently participating in another interventional clinical trial.
Subject is unsuitable for participation due to any other cause as determined by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shridhara A Karinka, PhD
Organizational Affiliation
Abbott Diabetes Care
Official's Role
Study Director
Facility Information:
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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