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
University of Otago
60 participants
May 31, 2021
Interventional
Conditions
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
Inclusion Criteria8
- Aged greater than or equal to 16 years
- Already using FGM (Abbot Free Style Libre) technology with no restrictions based on insulin regimen;
- Diagnosed with T1 Diabetes for at least 6 months;
- At least 0.5 units of insulin/kg/day;
- Plans to continue with routine clinical care during the whole period of the study;
- Intention for continuous use of FGM during the whole study period (17-week)
- Currently residing in and expecting to remain in regions served by the Capital and Coast District Health Board (DHB), Canterbury DHB. Waikato, Mid-central DHB, Hawkes Bay, and Southern District Health Boards for the next 21 weeks.
- Ability to understand study procedures, including English language proficiency, and to comply with them for the entire length of the study.
Exclusion Criteria9
- Already using DIY-CGMS or another CGM product (other than FGM)
- Any severe diabetes related complications (nephropathy requiring renal replacement therapy, retinopathy with associated visual loss – milder degrees will not be excluded);
- Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness.
- Participation in another device or drug study that could affect glucose measurements during the study period;
- Inability of the patient to give written informed consent.
- Plan to leave study regions prior to study completion.
- Pregnant or planning to become pregnant during the study.
- Using oral steroid medication (prednisone or another steroid) for two weeks or more prior to starting the study.
- Taking tablets or injections for type 2 diabetes such as GLP-1 and SGLT-2 inhibitors.
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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 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 .
Locations(1)
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ACTRN12621000648820