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Long term benefits of insulin pump use in people with type 1 diabetes

Long term follow-up on the real-world efficacy of insulin pump therapy in people with type 1 diabetes: retrospective cohort study.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000171314
Acronym
nil
Enrollment
400
Registered
2017-02-01
Start date
2017-02-06
Completion date
2017-05-31
Last updated
2017-02-06

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

Conditions

None listed

Brief summary

Insulin pump therapy is a potential long-term treatment options in patients with type 1 diabetes not achieving optimal glycemic control. Compared to standard care insulin pump therapy is expensive and requires high levels of medical and patient input, and its use in Australia is rapidly increasing. Despite this the potential long-term effects of insulin pump therapy in patients with type 1 diabetes in comparison with standard of care is poorly documented, with no studies published with more than 5 years of follow-up. The aim of this study is to review long term (5 to 16 years) follow-up clinic data relating to clinical outcomes (glycemic control, hypoglycaemia, weight, clinical service utilisation) between 2000 and 2016 of people commenced on insulin pump therapy compared to standard care which is people who have undergone formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011.. We intend to provide “real life” long term data to examine the efficacy and costs of on insulin pump therapy compared to modern standard care.

Interventions

This is a retrospective cohort study that does not involve participant recruitment/enrollment. Data collection will be from electronic medical records of clinical data routinely collected as part of clinical care. Clinic data obtained as part of patient follow-up will be collected from the electronic medical record of people commenced on insulin pump therapy compared to people provided with standard care which is a formalised training in insulin dose adjustment (FlexIt Program). People include

This is a retrospective cohort study that does not involve participant recruitment/enrollment. Data collection will be from electronic medical records of clinical data routinely collected as part of clinical care. Clinic data obtained as part of patient follow-up will be collected from the electronic medical record of people commenced on insulin pump therapy compared to people provided with standard care which is a formalised training in insulin dose adjustment (FlexIt Program). People included are those where commencement of insulin pump therapy or the FlexIt program was between 2000 and 2011. Clinic data will be collected from the time of commencement of nsulin pump therapy or the FlexIt program to December 2016 which is the end of follow-up.. Clinical outcome data that will be extracted includes: 1. demographic information – age and gender, duration of diabetes 2. glycemic control (HbA1c) 3. diabetes renal complications (albuminuria and eGFR) and cardiovascular risk factors (SBP and DBP, lipid profile (total cholesterol, LDL, HDL, triglycerides, weight) 4. utilization of health care resources and appropriate technical and practical use of insulin pump therapy (as determined from insulin pump data uploaded to computer on clinic visits)

Sponsors

Baker Heart and Diabetes Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

commencement of insulin pump therapy or undertaking of formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011 at the Baker Diabetes Clinical Services

Exclusion criteria

not being commencement of insulin pump therapy or not undertaking of formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011 at the Baker Diabetes Clinical Services

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026