ACTRN12617000785303Completed未知
The role of continuous glucose monitoring as a self-monitoring behaviour change tool to enhance glycemic control in individuals with type 2 diabetes - Pilot Study
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- CSIRO
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria
- •*Adults aged 20-75yrs (Male and Female)
- •*BMI 26-45kg/m2
- •* Diagnosed with Type 2 Diabetes
- •*With a HbA1c between 5.9-6.9% and ARE taking oral medications or insulin
- •* With a HbA1c between 7-12% with or without medications
- •* Must be willing to comply with the study procedures
- •*Have signed informed consent
- •*Able to attend appointments and live within the Adelaide Metropolitan area
- •*If female, not pregnant or breast feeding
- •*No history of heart disease or other heart abnormalities
- •*Do not strictly control or restrict the food and drinks that you have daily (i.e. *restrained eater questionnaire score greater than 10)
- •*Being weight stable (+/- 3kg) in the past 3 months
Exclusion Criteria
- •Exclusion Criteria
- •*Type 1 Diabetes
- •*Taking short acting insulin (i.e. Actrapid) Fitted with any electronic medical device / implant i.e. pacemaker
- •* Abnormality of clinical significance on medical history (including; current cancer, chronic lung disease, Depression, significant hormone problems (other than stable treated thyroid disease), kidney, respiratory, brain or gastrointestinal disease including gastrointestinal disease which may affect study outcomes)
- •* Any identified abnormality of specific blood or urine tests such as for liver function tests ((including ALT, AST or GGT greater than or equal to 2.5X upper limit of normal), Protein in the urine or HIV infection
- •*HBA1c greater than 12%
- •*BMI less than 26kg/m2 or greater than 45kg/m2
- •*Taking glucocorticoids such as prednisone [oral/inhaled or topical] within last 3 months.
- •* Use of illicit drugs
- •*Psychotropics other than a stable dose of an antidepressant
- •*Musculoskeletal problems that prevent physical activity
- •*History of heavy alcohol consumption (more than 2 standard drink on > 4 days per week)
- •*History of or current eating disorder
- •*Not willing to cease alcohol consumption for study duration
- •*Not willing to comply with study protocols
- •*Inability to prepare meals or meet dietary requirements
- •*Extended absences due to travel or other commitments
- •*Active/Current Gastro-Intestinal Disorders
- •*Past history of gastrointestinal surgery which may affect study outcomes (ie stomach surgery due to cancer)
- •*Diagnosed food intolerances (i.e. lactose intolerance)
- •*Medications which affect bowel movement or hunger /appetite (e.g.metoclopramide, domperidone and cisapride, anticholinergic drugs (eg atropine), erythromycin)
- •*Unable to comprehend the requirements of the study
Investigators
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