Diabetes Mellitus, Type 2NCT06591286
Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control
A study testing RT-CGM and SMBG in people with Diabetes Mellitus, Type 2, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- RT-CGM and SMBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 80 years old.
- Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
- 8% ≤ HbA1c ≤ 12% in the last 1 month.
- Insulin therapy within 1 month of planned discharge from hospital.
- Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
- Willing and able to provide written informed consent and comply with the requirements of this study.
Who cannot join
- Oral steroid hormone therapy.
- Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
- Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
- Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2).
- Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200233
Shiyun Wang, PhD, rhyme2008@alumni.sjtu.edu.cn
About this study
Official title: Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control and Self-efficacy Among Patients With Type 2 Diabetes Treated With Insulin
Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.
Read the detailed description
Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.
One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- RT-CGM, SMBG
- Keywords
- Continuous Glucose Monitoring
- 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.
RT-CGMDevice
This group of patients will wear RT-CGM for blood glucose monitoring for three months.
SMBGDevice
This group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group (75 cases) will wear real-time CGM to monitor blood glucose for 12 weeks, followed by 36 weeks of follow-up. Receives: Device: RT-CGM |
| Control group | Other | The control group (75 cases) is self-monitored by traditional SMBG for 12 weeks at a frequency of no less than 4 times a week, followed by 36 weeks of follow-up. Receives: Device: SMBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (3.9~10.0mmol/L, %)
Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
Measured: 12 weeks
Secondary outcomes (9)
HbA1c (%)
Glycated hemoglobin (%)
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time in range (3.9~10.0mmol/L, %)
Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
Measured: 4weeks, 8weeks, 24weeks, 48 weeks
Time above range (>10.0mmol/L, %)
Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM.
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time below range (<3.9mmol/L, %)
Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Coefficient of variation (CV)
Standard deviation divided by mean glucose level measured by CGM.
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Standard deviation (SD)
Standard deviation of blood glucose measurements during CGM.
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Mean amplitude of glycemic excursions (MAGE)
Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions.
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes management self-efficacy
The Chinese version of Diabetes Management Self-efficacy Scale (DMSES) is used to evaluate the patients' self-efficacy
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes Self Care Activities
The Chinese version of Summary of Diabetes Self Care Activities (SDSCA) is used to evaluate the patients' self-efficacy
Measured: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Oct 2024
- Primary completion10 Mar 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
- Investigators
- Jian Zhou, Dr., Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591286
- Sponsor's protocol ID
- RT20240903
- Status last verified
- Nov 2024
- First submitted
- 7 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control and Self-efficacy Among Patients With Type 2 Diabetes Treated With Insulin
- ClinicalTrials.gov ID
- NCT06591286
- Acronym / sponsor ID
- RT20240903
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.
Detailed description
Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.
One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: RT-CGMThe intervention group (75 cases) will wear real-time CGM to monitor blood glucose for 12 weeks, followed by 36 weeks of follow-up. |
| Control group | Other | Device: SMBGThe control group (75 cases) is self-monitored by traditional SMBG for 12 weeks at a frequency of no less than 4 times a week, followed by 36 weeks of follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old ≤ age ≤ 80 years old.
- Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
- 8% ≤ HbA1c ≤ 12% in the last 1 month.
- Insulin therapy within 1 month of planned discharge from hospital.
- Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
Key exclusion criteria (7 listed)
- Oral steroid hormone therapy.
- Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
- Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
- Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2).
- Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-CGMThis group of patients will wear RT-CGM for blood glucose monitoring for three months. | Device | Intervention group |
| SMBGThis group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week. | Device | Control group |
Primary outcome
Time in range (3.9~10.0mmol/L, %)
Time frame: 12 weeks
Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
9 secondary outcomes
HbA1c (%)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time in range (3.9~10.0mmol/L, %)
Time frame: 4weeks, 8weeks, 24weeks, 48 weeks
Time above range (>10.0mmol/L, %)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time below range (<3.9mmol/L, %)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Coefficient of variation (CV)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Standard deviation (SD)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Mean amplitude of glycemic excursions (MAGE)
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes management self-efficacy
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes Self Care Activities
Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Zhou, Dr. principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-CGM and SMBG in people with Diabetes Mellitus, Type 2, run by Shanghai 6th People's Hospital at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyun Wang, Dr. (+86 21 2405 8570, rhyme2008@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (3.9~10.0mmol/L, %) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.