real-time CGM
Devicereal-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Other names: rtCGM, RT-CGM
NCT Number: NCT07007676
The goal of this clinical trial is to learn if continuous glucose monitoring system works to improve glucose control in non-insulin-treated older adults with type 2 diabetes. The main questions it aims to answer are:
* Dose the use of continuous glucose monitoring system improve glucose control in older adults with type 2 diabetes treated with oral antidiabetic drugs only? * Dose the use of continuous glucose monitoring system affect psychological outcomes in older adults with type 2 diabetes treated with oral antidiabetic drugs only? Researchers will compare continuous glucose monitoring to standard blood glucose monitoring to see if continuous glucose monitoring works better in glucose management.
Participants will:
* Wear continuous glucose monitoring every 2 months or standard blood glucose monitoring for 6 months * Visit the clinic once every 2 months for follow-up * Keep a diary of their blood glucose when continuous glucose monitoring was not used
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Shenzhen Jiangangshan Health Service Center, Shenzhen, Guandong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Other names: rtCGM, RT-CGM
Time frame: 24 weeks from baseline
Change in HbA1c from baseline to 24 weeks
Time frame: 24 weeks from baseline
A treatment group comparison of percentage of time spent in glucose range between 70 and 180 mg/dL measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of percentage of time spent in glucose range below 70 mg/dL measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of percentage of time spent in glucose range above 180 mg/dL measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of glucose coefficient of variability measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of the mean glucose measured by CGM
Time frame: 24 weeks from baseline
Percentage of subjects with A1C less than 7%
Time frame: 24 weeks from baseline
Percentage of subjects with a reduction in A1C greater than or equal to 0.5%
Time frame: 24 weeks from baseline
Hypoglycemia event was defined as 15 consecutive minutes with a sensor glucose value <70 mg/dL
Time frame: 24 weeks from baseline
A treatment group comparison of the percentage of time spent in glucose range between 70 and 140 mg/dL measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of the glycemia risk index measured by CGM. Glycemia risk index (GRI) was calculated according to the following equation: GRI = (3.0×VLow) + (2.4×Low) + (1.6×VHigh) + (0.8×High).
Time frame: 24 weeks from baseline
A treatment group comparison of the glucose standard deviation measured by CGM
Time frame: 24 weeks from baseline
A treatment group comparison of the days to initiate inulin treatment during study period
Time frame: 24 weeks from baseline
Psychological-related events were measured by Diabetes Distress Scale and Patient Health Questionnaire-8 items.
Time frame: 24 weeks from baseline
Change in the score of blood glucose monitoring satisfaction questionnaire from 24 weeks from baseline
Contact information is provided by the study sponsor or research team.
Jian Zhou, Prof., Dr., Ph.D
CONTACT
Yaxin Wang, Dr.
CONTACT
Shanghai 6th People's Hospital
Other
Effect of contINuous Glucose moniToring System on glycEmic controL in Non-insuLin-Treated Elderly People With Type 2 Diabetes: a Randomized Controlled Trial
Acronym: INTELLECT
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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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