Methods
comorbidity, Diabetes, ketoacidosis, hypoglycemia, Diabetes Self-Management (SEDM).Data, diabetes
KETOACIDOSIS, ADVERSE EVENTS, EVENT, RECRUITMENT, HYPOGLYCEMIA, DIABETES, DIABETES, HYPOGLYCEMIA
This 12-week multisite 1: 1 randomized, 2-arm, parallel, controlled open-label study was conducted across five diabetes centers in New Zealand: Northland (NDHB), Auckland (ADHB), Bay of Plenty (BOPDHB), Capital and Coast (CCDHB), and Southern (SDHB) from October 2020 to August 2022. For full details, see the published study protocol.Eligibility criteria were children aged 4–13 years (inclusive), diabetes duration of ≥6 months, and HbA1c between 7.5% and 12.2% (58–110 mmol/mol) (at time of enrollment and insulin dose >0.5 U/[kg·d]). Exclusion criteria included continuous use of any CGM in the previous 3 months (excluding in-hospital), was defined by use of any CGM for ongoing week-to-week home use in the past 3 months—as opposed to a sensor provided by the clinic to capture 1–2 weeks of data as a one-off in the past 3 months, participation in any other study that could affect measurements, or any severe psychiatric/physical comorbidity, which may have treatment disrupted by agreeing to take part in the trial. Potentially eligible children from the participating sites were invited to participate, and interest was also taken from families at satellite sites following advertising on social media.Following consent, basic demographic information about children and their parents was collected at the screening visit with outcome measurements assessed at baseline and 12 weeks. HbA1c was measured using a calibrated point-of-care device (DCA Vantage analyzer; Siemens Healthcare Diagnostic Ireland). All consented and eligible participants were asked to wear a blinded sensor (Freestyle Libre Pro; Abbott) for up to 14 days (7 days minimum). While wearing the blinded sensor and before randomization, children and parents were asked to complete age-appropriate psychosocial questionnaires examining quality of life (PedsQL Diabetes Module 3.2 young child/child/teen version, as appropriate), fear of hypoglycemia (Hypoglycemia Fear Survey), and participants aged 10–14 years (inclusive) were also asked to complete the Self Efficacy for Diabetes Self-Management (SEDM).Data on adverse events, including severe cutaneous reactions and severe hypoglycemia and ketoacidosis were self-reported by phone or text messages, but no further contact was made between research staff and the participants in either group during the study period. All medical advice continued with their usual diabetes service (diabetes clinics are attended regularly [at least every 3 months] by a multidisciplinary team [pediatric endocrinologist/diabetologist/pediatrician, diabetes nurse specialist, dietitian, psychologist]).The treatment group allocation was revealed at visit 2, which coincided with the end of the 2-week blinded continuous interstitial glucose collection period. Participants were randomized in a 1:1 ratio to either the control (SMBG) group or the intervention (isCGM) group by research staff using a randomization module in REDcap.The first sensor was applied by research staff. Participants inserted the next sensor 14 days later themselves at home, and for the remainder of the study, and contacted research staff for technical support as required. Participants were instructed to scan a minimum of 6–10 times each day with no longer than 8 h between two scans, but no upper limit was set. The initial recommended reader alert settings were 3.9 mmol/L (70 mg/dL) and 15.0 mmol/L (270 mg/dL). These could be modified as required. As a safety precaution, participants were recommended to perform SMBG to confirm their glucose level before therapeutic interventions for hypoglycemia levels. To prevent sensor loss before the end of the 14-day sensor session, participants were shown examples of cohesive tape to be used to attach the sensor securely in the event the adhesive becomes loose.Control group participants continued SMBG using conventional finger-stick blood glucose (BG) testing with a glucometer but were recalled at week 10 to be refitted with a second blinded isCGM sensor, which they wore for weeks 10–12 of the study. This was used to compare with the isCGM data from the intervention group for the same 2 weeks.To maximize study recruitment, all participants received a second-generation isCGM in an open and supported 12-week extension phase after the RCT.