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Completed

NCT Number: NCT05150041

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung hospital

Seoul, South Korea

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Guardian connect

Device
  • 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.

iPro2

Device
  • 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.

Primary outcomes

  1. Change in HbA1c(%)

    Time frame: at 6 month

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

Secondary outcomes

  1. the target blood sugar (blood glucose) range

    Time frame: at 6 month

    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.

  2. changes in blood pressure(mmHg)

    Time frame: at 6 month

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

  3. changes in lipid parameter(mg/dl)

    Time frame: at 6 month

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

  4. changes in body weight(kg)

    Time frame: at 6 month

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

  5. changes in patient satisfaction level

    Time frame: at 6 month

    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,

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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