The effects of insulin pump therapy on an individual's physical & psychological well-being and cognition.

A study examining the physical, psychological and cognitive effects following commencement of continuous subcutaneous insulin infusion therapy (CSII) in Type I Diabetes.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000296033

Enrollment

Registered

2010-04-13

Start date

2010-04-01

Completion date

Unknown

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

The project aims to examine changes in glycosylated haemoglobin (which signifies stability of diabetes), physical, psychological and cognitive functioning following commencement of CSII therapy specifically measuring these parameters at three and six-month follow-up. The effect of CSII will be measured via routine blood tests, questionnaires examining physical health-related Quality of life (HRQoL), diabetes specific questions, psychological well-being and cognitive functioning. Patients will attend a review clinic at the Alfred specifically for CSII patients. Patients’ knowledge about their diabetes will be assessed pre and post CSII commencement (at several time points) using specific questionnaires and we will also measure glycaemic control via the recognized blood test of diabetes stability (HbA1c). The questionnaires used will include assessment of patients’ sense of empowerment, a self-care inventory on diabetes, a diabetes-specific treatment satisfaction questionnaire, and an emotional distress questionnaire that is diabetes specific. The aim is to assess whether CSII improves these aspects of an individual’s life with CSII. Within the project, we aim to set up a group pump review clinic for all patients commencing pump therapy at this hospital.

Interventions

Observational study examining the effect of Continuous Subcutaneous Insulin Infusion (CSII) in terms of physical, psychological and cognitive functioning of people with Type 1 diabetes. This study will administer questionnaires on quality of life and emotional well-being before and after the insulin pump is implanted. The overall study duration is one year with follow-ups at 3 and 6 months after pump insertion.

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

Patients with Type 1 Diabetes commencing CSII therapy Age 18 years to 69 years The capacity to give and accept informed consent to participate in the research

Exclusion criteria

Age under 18 years or >=70 years Chronic renal disease, stage III or IV Psychosis or psychiatric disorder Active cancer within last 5 years Inability to provide informed consent (i.e. has an intellectual disability, dementia) Unable to communicate in English

Outcome results