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

Phase 2

Completed

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001330639
• Lead Sponsor: Dr Donald Anderson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of time sensor glucose levels remain within range 3.9-10.0mmol/L as assessed by analysis of data exported from continous glucose sensor.[over 6 days observation]

Secondary Outcome Measures

Name	Time	Method
percentage time sensor glucose levels remain >=10mmo//L as assessed by analysis of data exported from continous glucose sensor. [over 6 days observation];percentage time sensor glucose levels remain <=3.9mmo//L as assessed by analysis of data exported from continous glucose sensor.[over 6 days observation];Number of times sensor glucose levels fall below 2.75mmol/L as assessed by analysis of data exported from continous glucose sensor.[over 6 days observation]