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Diabetes Mellitus, Type 2NCT05150041

The Efficacy of Guardian Connect to Modify Lifestyle in Patients With Type 2 Diabetes Mellitus

A study testing Guardian connect and iPro2 in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It has been demonstrated by many different researches that for patients to work on their lifestyle modifications, it is important that the patients know their exact blood glucose levels. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Guardian connect and iPro2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
7 Apr 2020to 7 Dec 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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients between 30 - 65 years old(based on birthdays)
  • Type 2 Diabetes Mellitus patients
  • Patients who have been taking three types of oral hypoglycemic agent for at least 12 weeks
  • Patients whose selection test show HbA1c as 7.5 ~ 10%
  • Patients who are willing to use the RT-CGM
  • Patients who have signed the letter of consent

Who cannot join

  • Type 1 Diabetes Mellitus patients
  • Gestational Diabetes patients
  • Patients who have undergone continuous or intermittent insulin treatments for more than 7 days within 12 weeks from the selection test date.
  • Patients who underwent oral or non-oral corticosteroid treatment for more than 7 continuous days 1 month before the selection test date.
  • Patients with history of hyperplastic diabetic retinosis
  • Patients with serious case of infection, scheduled for surgery, history of recent surgery, severe injury
Show all 11Show fewer
  • Patients with history of malignant tumor in five years
  • Patients whose records show history of drug abuse or alcoholism within 12 weeks from the questionnaire, medical report and past treatment reports
  • Female patients who are pregnant or breast -feeding
  • Patients who are participating in other clinical researches other than the current clinical research or who have taken other clinical test drugs within 4 weeks
  • Patients who are unfit to partake in this clinical research as determined by the researcher

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangbuk Samsung hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Pilot Study for the Efficacy of Guardian Connect to Modify Lifestyle in Patients With Type 2 Diabetes Mellitus

It has been demonstrated by many different researches that for patients to work on their lifestyle modifications, it is important that the patients know their exact blood glucose levels. Unlike the HbA1c which can only be determined at the hospital, improvements in blood glucose levels were detected in both the Type 1 Diabetes Mellitus patients who use insulin as well as Type 2 Diabetes Mellitus patients with SMBG(self-monitoring of blood glucose) which is the method used by patients to measure the blood glucose level at home on their own. Where SMBG needed blood to be collected from the fingertips, it has now passed the continuous glucose monitoring(CGM) stage where blood drawing is no longer required and is now replaced by the real-time CGM(RT-CGM) where blood glucose level can be checked real time. Type 2 Diabetes Mellitus patients who do not use preprandial rapid insulin were divided into SMBG group and intermittent RT-CGM user group and their blood glucose level decrease monitored for 3 months. After 3 months, HbA1c in SMBG group decreased 0.5% compared to the baseline while 1.0% decreased in RT-CGM group. The research was extended 40 weeks to make the total research period to 52 weeks and the results still showed that there were significant decrease in the RT-CGM group. However, up to this day, there are no researches that can show that there are additional decrease in the blood glucose level in Type 2 Diabetes Mellitus patients with use of RT-CGM in the group where sufficient blood glucose management cannot be achieved through use of three oral drug combination therapy to lower the blood glucose level.

This research seeks to find out if there are any decreases in the blood glucose level by using RT-CGM at 6 month period in Type 2 Diabetes Mellitu patient group whose blood glucose level cannot significantly be managed after the three oral hypoglycemic agent combination therapy.

Read the detailed description
  • Pilot, Prospective, open label, multicenter, 3 arm, randomized, feasibility study
  • Divided into below three groups iPRo2 only (Control group) / iPRo2 + RT-CGM 1 week treatment (Treatment group 1) / iPRo2 + RT-CGM 1 week on /3 weeks off (2 cycles) (Treatment group 2)
Being tested
Guardian connect, iPro2
Keywords
Diabetes self-management education
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Guardian connectDevice

    • Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period.
    • Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.

  • iPro2Device

    • Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period.
    • Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.
Study groups in NCT05150041
Study groupRoleWhat they receive
iPRo2 only (Control group)Active comparator- The Control group will go through target lifestyle coaching including diet and exercise and they will undergo 24 weeks of follow-up period.
Receives: Device: iPro2
iPRo2 + RT-CGM 1 week treatment (Treatment group 1)ExperimentalTreatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period.
Receives: Device: Guardian connect; Device: iPro2
iPRo2 + RT-CGM 1 week on /3 weeks off (2cycles) (Treatment 2)Experimental- Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.
Receives: Device: Guardian connect; Device: iPro2

What is being measured

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

  1. Change in HbA1c(%)

    This study aimed to see HbA1c(%) changes from baseline and 6month time frame.

    Measured: at 6 month

Secondary outcomes (5)

  1. the target blood sugar (blood glucose) range

    Comparing indicators such as CGM glycological matrices, Time in Range, etc. at 6 months period to the baseline in each group. Time in range is the amount of time you spend in the target blood sugar (blood glucose) range-between 70 and 180 mg/dL as a normal.

    Measured: at 6 month

  2. changes in blood pressure(mmHg)

    Comparing the changes in blood pressure to the baseline in each group at 6 month period.

    Measured: at 6 month

  3. changes in lipid parameter(mg/dl)

    Comparing the changes in lipid parameter to the baseline in each group at 6 month period.

    Measured: at 6 month

  4. changes in body weight(kg)

    Comparing the changes in body weight to the baseline in each group at 6 month period.

    Measured: at 6 month

  5. changes in patient satisfaction level

    Comparing the changes in patient satisfaction level to the baseline in each group at 6 month period. (assessed by The Summary of Diabetes Self-Care Activities Measure,

    Measured: at 6 month

Timeline

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

  1. First posted8 Dec 2021
  2. Study start7 Apr 2020
  3. Primary completion7 Dec 2021
  4. Study completion7 Dec 2021

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
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150041
Sponsor's protocol ID
KBSMC 2019-04-021
Status last verified
Mar 2022
First submitted
9 Oct 2019
Last updated
8 Mar 2022
Results posted
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 Guardian connect and iPro2 in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital at 1 site in South Korea.

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 8 Mar 2022. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in HbA1c(%) (time frame: at 6 month). 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 NCT05150041.

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 8 Mar 2022.

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