Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment.
OBJECTIVE
The value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined.


METHODS
A total of 160 children (aged 1-16 years, mean ± SD: 8.7 ± 4.4 years; 47.5% girls) were randomised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements. The primary outcome was the level of HbA(1c) after 12 months. Other analyses included fasting C-peptide, glycaemic variability, sensor usage, adverse events, children's health-related quality of life and parent's wellbeing.


RESULTS
HbA(1c) was not significantly different between the two groups, but patients with regular sensor use had lower values (mean 7.1%, 95% CI 6.8-7.4%) compared with the combined group with no or low sensor usage (mean 7.6%, 95% CI 7.3-7.9%; p=0.032). At 12 months, glycaemic variability was lower in the sensor group (mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7; p=0.037). Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients (0.25 ± 0.12 nmol/l) compared with those treated with insulin pump alone (0.19 ± 0.07 nmol/l; p=0.033). Severe hypoglycaemia was reported only in the group without sensors (four episodes).


CONCLUSIONS
Sensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children, although regular sensor use is a prerequisite for improved glycaemic control.


BACKGROUND
ISRCTN.org ISRCTN05450731


BACKGROUND
Medtronic International Trading Sàrl, Tolochenaz, Switzerland.
Kordonouri
O
O
Bult Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult, Janusz-Korczak-Allee 12, D-30173 Hannover, Germany.
Pankowska
E
E
Rami
B
B
Kapellen
T
T
Coutant
R
R
Hartmann
R
R
Lange
K
K
Knip
M
M
Danne
T
T
D000293:Adolescent; D017668:Age of Onset; D015374:Biosensing Techniques / Q000295:instrumentation* / Q000379:methods; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007223:Infant; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D011788:Quality of Life; D013997:Time Factors
D007004:Hypoglycemic Agents; D007328:Insulin