NCT05319496Completed
isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes
Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures glucose levels under the skin. With intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is painless, provides information on glucose trends, and has improves patient satisfaction. Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well studied in this population. In this randomized trial, we are looking for adults with type 2 diabetes, who need further blood glucose lowering (HbA1c \> 7.0%), who are not yet on insulin. Participants randomized to the treatment group (50%) will receive isCGM with individual coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors (6 weeks), and is intended to be affordable and applicable to a wide range of adults with diabetes under real world conditions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 31 Mar 2022
- Start date
- 5 Oct 2022
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- University of Alberta
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05319496
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From 5 Oct 2022 to the primary completion date, 15 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any use of insulin in the previous year.
- Current or previous use of isCGM or rtCGM within the last 6 months.
- Concurrent participation in a different diabetes-related trial.
- Has not already received two doses of a Health Canada-approved vaccine against SARS-CoV-2.
Other illness
- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: MODY).
- Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.
- Any terminal condition that would limit life expectancy to \< 1 year.
Other
- Pregnancy; plans to become pregnant within 6 months; breast-feeding.
- Cognitive dysfunction (SPMSQ score \>= 5).
- Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and weight loss, accompanied by acute fatigue or dyspnea).
- Inability to use isCGM (e.g.: afraid of the device).
- Inability to be reached by telephone.
Who the study is looking for
- Age \>= 18 years with type 2 diabetes.
- HbA1c \> 7.0% within the last 6 months.
- Non-insulin therapy.
- Able to attend two in-person study visits.
- English-speaking.
- Community-dwelling
- In possession of a cell phone capable of accessing the internet and receiving FreeStyle Libre 2 sensor readings
- Has a primary care provider who has been in contact with the patient for diabetes in the last 12 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital/Kaye Edmonton Clinic Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.