None listed
Conditions
Brief summary
The randomised crossover trial will investigate the effectiveness of a flash glucose monitoring (FGM) system converted to a continuous glucose monitoring system (MiaoMiao CGMS) vs standard FGM in a real-world setting among children with type 1 diabetes. In total, 55 participants will be enrolled and randomised to either the intervention (MiaoMiao CGMS) or control group (standard FGM). After the first 6 week trial phase, there will be a 4 week washout period, followed by a further 6 week trail phase in which all participants will crossover to the other study group. We hypothesise that MiaoMiao CGMS will reduce parental and child fear of hypoglycemia.
Interventions
The 17-week trial duration includes a 1 week run-in phase to collect baseline data followed by a 6-week phase during which the intervention group will commence the intervention and the control group will continue their usual glucose monitoring approach. This phase will be followed by a wash out period of 4 weeks to eliminate any carry-over effect. During the last phase, the participants will crossover between groups for an additional 6 weeks.
The standard Flash Glucose Monitoring (FGM) (Abbott
The 17-week trial duration includes a 1 week run-in phase to collect baseline data followed by a 6-week phase during which the intervention group will commence the intervention and the control group will continue their usual glucose monitoring approach. This phase will be followed by a wash out period of 4 weeks to eliminate any carry-over effect. During the last phase, the participants will crossover between groups for an additional 6 weeks. The standard Flash Glucose Monitoring (FGM) (Abbott FreeStyle Libre) which will be in use by all participants at study commencement (inclusion criteria) consists of an easy to apply, wear and use interstitial glucose sensor and glucose reader. The sensor is worn in the upper arm for up to 14 days. In addition to this pre-existing FGM, the intervention group will receive the MiaoMiao device which is a small cap that attaches directly to the FGM sensor. The MiaoMiao transmits sensor data via BluetoothTM to an app on the child’s phone or smartwatch (xDrip+/Spike/GLIMP/Tomato - depending on compatibility with the mobile device’s operating system). This displays continuous glucose data on the child’s mobile device. The parents/caregivers will also have the option of “following” this data on their smart phones as well as provide safety alarms in response to low or high glucose levels, even when not in Bluetooth™ range. It is anticipated that this data will be used to help children and their families make usual insulin dosing and other management decisions (replacing their use of FGM). No additional intervention will be provided during the 6-week intervention period (other than appropriate MiaoMiao CGMS training/technical support). All participants after completion of RCT will have the chance to keep their MiaoMiao transmitter. Adherence to the 6-week intervention can be measured by review of the relevant app data, which will be downloaded for analysis at completion of the intervention.
Sponsors
Department of Women's and Children's Health, University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1) Aged 13 years and under with a parent/caregiver involved in diabetes management; 2) Already using flash glucose monitoring (FGM) technology with no restrictions based on insulin regimen; 3) Diagnosed with type 1 diabetes for at least 6 months; 4) Equal to or greater than 0.5 units of insulin/kg/day; 5) Plans to continue with routine clinical care during the whole period of the study; 6) Intention for continuous use of FGM during the whole study period 7) Currently residing in and expecting to remain in regions served by the Canterbury, Capital and Coast, Mid-central, South Canterbury, Auckland, and Southern District Health Boards for the following year. 8) Ability to understand study procedures, including English language proficiency, and to comply with them for the entire length of the study.
Exclusion criteria
1) Already using MiaoMiao continuous glucose monitoring system (CGMS) or another CGMS product (other than FGM) 2) Any severe diabetes-related complications (nephropathy on treatment, retinopathy with associated visual loss – milder degrees will not be excluded); 3) Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness; 4) participation in another device or drug study that could affect glucose measurements during the study period; 5) Inability of a legal guardian to give written informed consent and/or provide day to day diabetes management input. 6) Plan to leave study regions prior to study completion.
Outcome results
None listed