A clinical trial will test whether giving teenagers with newly diagnosed type 1 diabetes an automated insulin pump from day one can preserve their remaining insulin-producing cells. The body’s own insulin production declines rapidly after diagnosis, forcing patients to rely entirely on injected insulin for the rest of their lives. Even small amounts of residual insulin dramatically improve long-term glucose control and reduce complications. Current standard care—multiple daily injections—struggles to maintain tight glucose control, especially in the chaotic first year of diagnosis. Closed-loop systems, which automatically adjust insulin delivery based on continuous glucose readings, might protect the pancreas from further damage by keeping blood sugar consistently stable. If the closed-loop system preserves significantly more C-peptide (a marker of insulin production) after one year compared to injections, it would change clinical practice. NICE guidelines could shift to recommend automated insulin delivery from diagnosis. For patients, retaining even partial insulin function means fewer dangerous hypos, less erratic blood sugar, and lower risk of long-term complications like kidney disease and blindness. The trial also includes interviews with families to understand whether the burden of wearing a device is worth the metabolic benefit.
View original technical description
Setting: 5 paediatrics diabetes clinics. Each site will recruit 10-14 participants per year (n=20 over 22 months). Target population: Youth aged 10-17.9 yrs, with newly diagnosed T1D within previous 2 weeks. Treatments being assessed: Two forms of insulin delivery each aiming for the tightest glucose control safely achievable. (a) CL: Patients will be treated by Novorapid delivered by closed loop system overnight and between meals, with bolus doses at meal times. (b) MDI (Pen) intervention: Basal bolus analogue regimen (NovoRapid with Glargine), using a Pen Injection device. Consent will be taken for potential longer term follow-up/linkage studies. Assessments: Consented participants with T1D will be randomised to receive CL or MDI over 12 months. Study visits for both interventions will occur at baseline, 3, 6, 9, and 12 months post diagnosis. Each visit will include medication history, physical exam, urine pregnancy test (for females with reproductive potential), HbA1c assessment. At baseline and 12 months, mixed meal tolerance test (at Clinical Research Facility) will be performed and blood samples for immunological assessment taken. At 6 months, in-depth qualitative interviews will be undertaken in a subset of 15-20 parents and 15-20 youth. Primary Outcome: C-peptide area under the curve in response to a mixed meal (MMTT) at 1 year following diagnosis of type 1 diabetes. This outcome measures reliably residual insulin secretion (Greenbaum et al. 2008;Palmer et al. 2004) tightly coupled to long-term glucose control and diabetes complications (Steffes et al. 2003;The Diabetes Control and Complications Trial Research Group. 1998). Retention of residual C-peptide secretion would change clinical practice and influence NICE guidelines. Key Secondary Biomedical Outcomes: HbA1c levels over time, insulin dose, hypoglycaemia burden, severe hypoglycaemic events. Psychosocial: Perceptions of lifestyle change, diabetes management, quality of life and fear of hypoglycaemia (questionnaires), qualitative interviews. Analyses: Intention to treat (ITT), with secondary per protocol analyses. Primary endpoint is the comparison between the two treatment arms will be based on a treatment effect in an ANCOVA model adjusting for gender, presence or absence of DKA, age and baseline log(C-peptide+1). Sample size information: The primary analysis will compare the difference between groups in the levels of the 2-hour AUC-mean using the log (mean C-peptide+1). The lower 90% confidence limit for the mean log(C-peptide + 1) value is 0.315 and the upper 90% confidence limit for the RMSE is 0.167. The expected Geometric-like mean C-peptide value in the treatment arm is 0.370*1.50 = 0.555 pmol/mL. A total sample size of 88 participants provides power of 90% to detect a 50% increase in the geometric-like mean C-peptide relative to the standard treatment group using a test at the 0.05 level (two-sided) The 50% difference in the geometric-like mean C-peptide meal response is commonly accepted treatment effect of immune intervention trials (Lachin et al. 2011). Allowing for 10% loss to follow up means we would need a total of 96 participants (48 per group). Team expertise: international leaders closed loop, T1D, youth /continuous glucose monitoring/pumps, multi-centre trials, methodology, statistics.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know