PumpTune computer recommended insulin pump settings compared to Doctor advised settings in children with Type 1 Diabetes: A randomised controlled trial

A randomised cross-over trial in children with Type 1 Diabetes to compare insulin pump settings set by PumpTune computerised algorithm to Doctor advised settings

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001330639

Enrollment

Registered

2014-12-18

Start date

2012-11-12

Completion date

2014-03-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Information from continuous glucose sensors is complicated. Insulin pumps can be set in many ways and the settings are complicated and may vary depending of the person making the changes. This study compares the results after insulin pumps are adjusted by a doctor or by a computer program.

Interventions

Children have the settings controlling their insulin infusion pumps adjusted by a credentially diabetes educator using recommendations from PumpTune computer algorithm once and then are monitored with continuous glucose monitoring for a further six days. There was no washout period separating these six days from the comparison period.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

Inclusion criteria

HbA1c in range 6.5-9.5% Diabetes was diagnosed at least 12 months previously Performing >=4 finger prick blood glucose levels each day Delivering at least six bolus doses of insulin each day

Exclusion criteria

Not able to attend John Hunter Hospital for three consecutive weeks to have sensors inserted and pumps adjusted

Outcome results