RecruitingACTRN12621000648820

Wearing your Continuous Glucose Monitor on your Sleeve : A Trial in Adults with Type 1 Diabetes

A Randomised Cross Over Trial Investigating the Impact of Smart Watch Integrated Do-it-yourself (DIY) Continuous Glucose Monitoring on Glycaemic Control in Adults with Type 1 Diabetes

Sponsor

University of Otago

Enrollment

60 participants

Start Date

May 31, 2021

Study Type

Interventional

Conditions

Glycaemic control Type 1 Diabetes

Summary

60 adult volunteers aged 16 years and over with type 1 diabetes will take part in this crossover randomized controlled trial . After a run-in period of one week, participants will be randomized to either MiaoMiao DIY-CGM use or continued FGM use for eight weeks. We hypothesize that using a novel DIY-CGM will improve Time in Range and other measures of glycaemic control compared to using isCGM alone. The primary outcomes are to compare the proportion of time spent in the target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) at baseline (pre-randomization) to weeks 19-21 of the study. Our secondary outcomes will include -longer-term glycaemic control while using AHCL as measured by glycated hemoglobin (HbA1c) at 9,13 and 21 weeks compared to pre-study baseline. -Psychosocial outcomes include fear of hypoglycemia, diabetes-related distress, partner distress, sleep quality, and awareness of hypoglycemia - longer-term safety (as defined by severe hypoglycemia, Diabetic ketoacidosis, adverse device events (expected and unexpected). The study will be conducted in Canterbury, Otago, Southland , Hawkes Bay, Wellington, and Waikato .

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

People with type 1 diabetes need to monitor their blood sugar carefully to avoid dangerous highs and lows. Many already use a Flash Glucose Monitor (like the Abbott FreeStyle Libre), which requires scanning the sensor to get a reading. A newer DIY continuous glucose monitor (DIY-CGM) called MiaoMiao automatically transmits glucose readings to a smartphone in real time, providing alerts and trends without needing to scan. This trial compares the two approaches to see whether the always-on CGM leads to better blood sugar control. The study runs for about 21 weeks and involves a crossover design — participants will use each device for a period so researchers can compare how well each keeps blood sugar in the target range. The study also looks at quality of life, fear of low blood sugar, and sleep quality. You may be eligible if you are 16 or over, have had type 1 diabetes for at least 6 months, and are already using the FreeStyle Libre. You must be residing in one of the participating New Zealand health districts for the duration of the study. People who are pregnant, using other types of CGM, or taking GLP-1 or SGLT-2 medications are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a multicentre randomized controlled crossover trial investigating the impact of do-it-yourself continuous glucose monitoring (DIY-CGM) compared to Flash Glucose Monitoring(FGM) alone on optim

This is a multicentre randomized controlled crossover trial investigating the impact of do-it-yourself continuous glucose monitoring (DIY-CGM) compared to Flash Glucose Monitoring(FGM) alone on optimizing glycaemic control. DIY-CGM uses near field communication to detect the signal/raw data generated by FGM and broadcasts it to a Bluetooth enabled device such as a watch or phone. Our study will utilise a study phone (android) to broadcast DIY-CGM glucose levels to a fit bit versa 2 smart watch. Both devices will be provided by the study team. Participants will be educated using a mixture of online and printed sponsor(University of Otago) derived instruction manuals and troubleshooting guides. The intervention(s) will be administered by an adult Endocrinologist(independent of the clinic treating team) together with two research nurses. The trial will be a randomized crossover trial with two 8 week intervention periods and a 4-week washout. The primary outcome is time in range from baseline compared to end of study(week 21). Expected duration of subject participation is 21 weeks .