Status:
COMPLETED
Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborating Sponsors:
Imperial College London
Oxford Brookes University
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patient Empowerment through Predictive PERsonalised Decision Support (PEPPER) is an European Union (EU) funded research project to develop a personalised clinical decision support system for Type 1 Di...
Detailed Description
1. Decision support algorithm: The decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by appl...
Eligibility Criteria
Inclusion
- Adults ≥18years of age
- Diagnosis of T1DM for \> 1 year
- On MDI using a basal-bolus insulin regime or CSII (insulin pump) for at least 6 month
- Structured education done and good ability perform carbohydrates (CHO) counting
- HbA1c ≥ 48mmol/mol and ≤ 86mmol/mol
- Using insulin carbohydrates ratio (ICR) and insulin sensitivity factor (ISF) to calculate the mealtime bolus
- An understanding of and willingness to follow the protocol and sign the informed consent
- CBG measurements at least 2 times per day for calibration of the CGM
Exclusion
- Severe episode of hypoglycaemia (requiring 3rd party assistance) in the 6 months prior to enrolment
- Diabetic ketoacidosis in the last 6 months prior to enrolment
- Impaired awareness of hypoglycaemia (based on Gold score)
- Pregnancy, breastfeeding or intention of becoming pregnant over time of study procedures
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour
- Gastroparesis
- Autonomic neuropathy
- Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study)
- Visual impairment including unstable proliferative retinopathy
- Reduced manual dexterity
- Inpatient psychiatric treatment
- Abnormal renal function test results (calculated Glomerular Filtration Rate (GFR) \<40 mL/min/1.73m2)
- Liver cirrhosis
- Not tributary to optimization to insulin therapy
- Abuse of alcohol or recreational drugs
- Oral steroids
- Regular use of the acetaminophen, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation.
- Participant withdrawal criteria:
- Loss of capacity to give informed consent
- The subject has a serious event related to study
- Cessation of MDI of insulin as usual care for T1DM
- Severe hypoglycaemia
- Diabetic ketoacidosis
- Positive pregnancy test
- Terminal illness
- Investigators initiated discontinuation of study due to participant or equipment concerns
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03849755
Start Date
November 15 2018
End Date
November 9 2019
Last Update
August 4 2020
Active Locations (1)
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1
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Spain, 17007