Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2023-03-23

Brief Summary

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We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.

Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.

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Detailed Description

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Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study

This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.

It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.

Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.

Conditions

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Diabetes Mellitus, Type 2 Lifestyle Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FreeStyle Libre (CGM) Group

Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification

Group Type EXPERIMENTAL

FreeStyle Libre

Intervention Type DEVICE

Flash glucose monitoring + Education on lifestyle modification

Self Monitoring of Blood Glucose (SMBG) Group

Device: Blood glucose meter Education on lifestyle modification

Group Type ACTIVE_COMPARATOR

Blood glucose meter

Intervention Type DEVICE

Self monitoring of blood glucose + Education on lifestyle modification

Interventions

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FreeStyle Libre

Flash glucose monitoring + Education on lifestyle modification

Intervention Type DEVICE

Blood glucose meter

Self monitoring of blood glucose + Education on lifestyle modification

Intervention Type DEVICE

Other Intervention Names

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Education on lifestyle modification Education on lifestyle modification

Eligibility Criteria

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Inclusion Criteria

* Age 19-80
* Diagnosed with type 2 diabetes mellitus (DM)
* Uncontrolled type 2 DM: HbA1c 7.0-10.0%
* Signed informed consent

Exclusion Criteria

* Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
* Use of prandial insulin
* Change in diabetes medication in the preceding 3 months
* Pregnant/lactating women
* Addiction to drugs and alcohol
* Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
* Severe liver disease
* End-stage renal disease (i.e. on dialysis)
* Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
* Conditions that impact the stability of HbA1c measurement

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No