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Type1 Diabetes MellitusFSL-MNCT04147637

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

A study testing FreeStyle Libre with MiaoMiao and FreeStyle Libre alone in people with Type1 Diabetes Mellitus, run by Dasman Diabetes Institute at 1 site in Kuwait.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Type1 Diabetes Mellitus
What is being tested?
FreeStyle Libre with MiaoMiao and FreeStyle Libre alone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteKuwait
Study dates
14 Oct 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Kuwait1 site

  • Ali Aldibbiat

    Kuwait City, 15462

Other trials in Kuwait

About this study

Official title: Crossover Randomized Controlled Trial of FreeStyle Libre Plus Bluetooth Transmitter Compared to FreeStyle Libre Alone in People With Type 1 Diabetes Mellitus. Can This Improve Accuracy and Reduce Burden of Hypoglycaemia

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.

Read the detailed description

Study design:

Open-label, crossover, single center, randomized controlled trial of FreeStyle Libre with MiaoMiao Bluetooth transmitter adjunct with calibrations (FSL-M) compared to FreeStyle Libre alone (FSL-A) in people with T1DM.

Protocol summary:

Following informed written consent, subjects will be randomized to either FSL-M group using FSL with Miaomio and Tomato App premium version, or FSL-A with Libre Link app (stage 1). Subjects will spend 8 weeks in the assigned group followed by 2 weeks washout then subjects will switch over to the other group for further 8 weeks (stage 2).

While in FSL-M, subjects will be asked to calibrate FSL with daily capillary glucose values using Contour Plus, or on days 1, 2, 4, 8, 13 of sensor life. Alarms for low glucose (<3.9mmol/L, <70mg/dL) and high glucose (>13.9mmol/L, 250mg/dL) will be set in Tomato App.

7-point capillary glucose profiles will be carried out by subjects in both groups on days 2/3, 5/6, 9/10, 13/14 of each sensor life to enable paired comparison with sensor values.

Subjects will have routine labs at randomization, end of stage 1, and end of stage 2. All subjects will be asked to complete the following questionnaires: GOLD, Problem Areas in Diabetes (PAID) and Diabetes Quality of Life (DQOL) at randomization, at end of stage1 and end of stage 2. The group randomized to FSL-M at stage 1 will have qualitative interview at randomization, end of stage 1 and end of stage 2.

All adverse events will be collected including, but not limited to, all hypoglycaemia, diabetic ketoacidosis, hospital admissions for any reason, and device related skin reaction for the duration of the study in all subjects in both groups.

Data analysis will be carried out on glucose data retrieved from Libre view web-platform and Tomato App downloads in addition to Contour Plus meter downloads.

Being tested
FreeStyle Libre with MiaoMiao, FreeStyle Libre alone
Keywords
Hytpoglycemia, FreeStyle Libre, Flash Glucose Monitoring, MiaoMiao, Time in Range

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FreeStyle Libre with MiaoMiaoCombination product

    Also called FSL-M

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

  • FreeStyle Libre aloneDevice

    Also called FSL-A

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

Study groups in NCT04147637
Study groupRoleWhat they receive
FSL-MExperimentalFreeStyle Libre + MiaoMiao Bluetooth adjunct with mobile application
Receives: Combination Product: FreeStyle Libre with MiaoMiao
FSL-AActive comparatorFreeStyle Libre alone
Receives: Device: FreeStyle Libre alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 9 months

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

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

    Measured: 9 months

  3. 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

    Measured: 9 months

Secondary outcomes (7)

  1. Percentage time <4mmol/L (72mg/dL)

    to evaluate general hypoglycaemia

    Measured: 9 months

  2. Percentage time >10mmol/L

    To evaluate hyperglycaemia

    Measured: 9 months

  3. Change in HbA1C

    To evaluate for any change in overall diabetes control

    Measured: 9 months

  4. Rate of hypoglycaemia

    number of episodes of hypoglycaemia

    Measured: 9 months

  5. Rate of severe hypoglycaemia

    number of episodes of severe hypoglycamia

    Measured: 9 months

  6. Rate of device-related complications

    This is specific for Libe and/or MiaoMiao

    Measured: 9 months

  7. Change in dose of insulin

    This will compare before and at end of each phase total daily insulin dose

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start14 Oct 2020 (estimated)
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Why it stopped: due to irrelevancy of the idea given the advancement in the field and COVID-19 crisis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized crossover study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147637
Sponsor's protocol ID
RA HM-2019-027
Acronym
FSL-M
Status last verified
Oct 2019
First submitted
30 Oct 2019
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FreeStyle Libre with MiaoMiao and FreeStyle Libre alone in people with Type1 Diabetes Mellitus, run by Dasman Diabetes Institute at 1 site in Kuwait.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean absolute relative difference (MARD) (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04147637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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