FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia

NCT04147637 | Withdrawn

• 1 other identifier: RA HM-2019-027
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced glucose monitoring systems have revolutionized diabetes care and enabled people with diabetes to achieve better diabetes control with reduced risk of hypoglycaemia. Continuous glucose monitoring (CGM) systems provide real-time glucose monitoring and alarms when glucose approaches extreme readings (hypoglycaemia and hyperglycaemia) or when the change in glucose is rapid. All available CGM systems, except Dexcom G6, require daily calibrations with capillary glucose readings in order to attain accuracy of glucose readings. Decom G6 system is not widely accessible and only available in certain countries. Flash glucose monitoring systems (Flash) provide glucose readings when users actively scan their sensors. FreeStyle Libre (FSL) is the only Flash glucose monitoring system currently available in market. FSL is factory calibrated and sensors are ready to use after placement and initiation. The two main differences between Flash and CGM are user interaction and the alarm facility. While CGM provide real-time glucose readings, Flash is user-dependent for actively scanning and understanding the readings. Moreover, CGM systems provide alarms for low or high glucose and for rapid glucose changes, while Flash does not routinely provide alarms. This is particularly relevant when patients have impaired or lost hypoglycaemia awareness. CGM systems are costlier compared to Flash, which has contributed to the wider adoption of FSL. Several Bluetooth adjuncts have been introduced to market for FSL. These devices attach to Libre sensor and connect to the user's mobile phone via Bluetooth. This enables continuous and real-time feed of glucose readings from the sensor to patient's mobile phone, which enables a wide range of customizable alarms for high and low glucose levels and for rapid glucose changes. This setup also enables calibration of Libre sensor with capillary glucose which, anecdotally, has been reported to improve sensor accuracy. None of these adjuncts have been validated clinically. FSL with Bluetooth adjunct such as MiaoMiao remain cheaper than current CGM options and could be more accessible in some countries than CGM. However, without robust evidence to support effectiveness and safety of such setup it is not possible to recommend this. The Objective of this study is to determine whether FSL with Bluetooth Adjunct is superior to FSL alone in accuracy and reduction of hypoglycaemia burden.

Conditions

Type1 Diabetes Mellitus

Keywords

Hytpoglycemia; FreeStyle Libre; Flash Glucose Monitoring; MiaoMiao; Time in Range

Outcome Measures

Primary Outcomes (3)

• Mean absolute relative difference (MARD)

  Comparing difference between glucose readings from the sensor in comparison to reference paired capillary glucose readings. This is to enable assessing accuracy of the intervention with FSL and MiaoMiao

  9 months

• Percentage time below 3.0mmol/L (54mg/dL)

  This is to enable evaluating burden of hypoglycaemia. Analysis will be done on sensor glucose data

  9 months

• Percentage time in range 4-10mmol/L

  This is to enable effect on time spent in normoglycaemia. Analysis will be done on sensor glucose data

  9 months

Secondary Outcomes (7)

• Percentage time <4mmol/L (72mg/dL)

  9 months

• Percentage time >10mmol/L

  9 months

• Change in HbA1C

  9 months

• Rate of hypoglycaemia

  9 months

• Rate of severe hypoglycaemia

  9 months

Study Arms (2)

FSL-M

EXPERIMENTAL

FreeStyle Libre + MiaoMiao Bluetooth adjunct with mobile application

Combination Product: FreeStyle Libre with MiaoMiao

FSL-A

ACTIVE COMPARATOR

FreeStyle Libre alone

Device: FreeStyle Libre alone

Interventions

FreeStyle Libre with MiaoMiao COMBINATION_PRODUCT

Use of FreeStyle Libre with MiaoMiao Bluetooth adjunct and mobile device application to enable calibration and alarms

Also known as: FSL-M

FSL-M

FreeStyle Libre alone DEVICE

Use of standard FreeStyle Libre with Libre Link app and mobile phone scanning

Also known as: FSL-A

FSL-A

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T1DM for 12 months or more
• Age \>21 years old
• Established user of FreeStyle Libre for ≥3 months
• HbA1C \<12% (108mmol/mol)
• Able to check glucose with finger prick several times a day

You may not qualify if:

• Pregnancy or plans for pregnancy over the duration of the study
• Breast feeding
• Renal impairment with eGFR \<30ml/minute/1.73m2
• Significant anaemia (males Hb\<110g/L, females Hb \<100g/L)
• Active malignancy
• Significant vision impairment
• Any significant illness- decision will be made by the PI or Co-I
• Not able to attend study visits
• Not able or not willing to participate in all study components
• Not able or not willing to give written informed consent

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Ali Aldibbiat

Kuwait City, 15462, Kuwait

Location

Study Officials

• Ali Aldibbiat, MD PhD FRCP

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover study

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: October 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: August 31, 2021
• Last Updated: February 10, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)