Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 12 for:    18779236 [PUBMED-IDS]

Patient Empowerment Through Predictive Personalised Decision Support (PEPPER) (PEPPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03186300
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Imperial College London
Oxford Brookes University
University of Girona
Cellnovo Limited
Romsoft SRL
Information provided by (Responsible Party):
José Manuel Fernández-Real, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection.The principal research objectives are to assess the usability, safety, and technical proof of concept and feasibility of the PEPPER in participants with T1DM. Evaluation of safety is a priority and will be assessed throughout the clinical studies. The safety components only of the PEPPER system will initially be evaluated in an out-of-clinic environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia, evaluate usability and incidence of technical faults. Following the initial safety study, the overall PEPPER system (integrated with the CBR algorithm) will be assessed (phase 2) and the primary outcome will be percentage time spent in hypoglycaemia.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: PEPPER system Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Patient Empowerment Through Predictive Personalised Decision Support (PEPPER)
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
PEPPER
In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).
Device: PEPPER system
In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).




Primary Outcome Measures :
  1. Change in the percentage of time spent in hypoglycaemia (glucose level below 3, 9 mmol/L or 70 mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
    The primary outcome is the percentage of time spent in hypoglycaemia defined as glucose level below 3.9 mmol/L (measurement used in UK) or below 70 mg/dl (measurement used in Spain).


Secondary Outcome Measures :
  1. Number of incidence of low glucose alarms [ Time Frame: Evaluation during the intervention period (6 week period) ]
    Glucose thresholds for hypoglycaemia are defined to alert (forecasted glucose values) or to alarm (glucose measurements) the user when they are violated by the forecasted or actual glucose values.

  2. Number of incidence of high glucose alarms [ Time Frame: Evaluation during the intervention period (6 week period) ]
    Glucose thresholds for hyperglycemia are defined to alert (forecasted glucose values) or to alarm (glucose measurements) the user when they are violated by the forecasted or actual glucose values.

  3. Number of incidence of carbohydrate adviser [ Time Frame: Evaluation during the intervention period (6 week period) ]
    Recommendation of dose of oral carbohydrate intake to address hypoglycaemia

  4. Number of incidence of low glucose suspend [ Time Frame: Evaluation during the intervention period (6 week period) ]
    Alarm of low glucose suspend is an alarm that announce the reduction or suspension of insulin delivery if predicted glucose values fall below a predefined threshold (only for pump users).

  5. Number of incidence of fault detection alarm [ Time Frame: Evaluation during the intervention period (6 week period) ]
    The fault detection algorithm allows detecting faults in the insulin infusion system and the continuous monitoring system.

  6. Change in the percentage of time in glucose target range (glucose levels 3.9-10 mmol/l or 70 - 180 mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  7. Change in the percentage of time in hyperglycaemia (glucose level above 10 mmol/l or 180 mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  8. Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 4 hours [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  9. Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 6 hours [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  10. Change in the post-prandial glucose level at 120 minutes (mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  11. Change in the post-prandial glucose level at 120 minutes (mmol/l) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  12. Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours (min x mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  13. Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours (min x mmol/l) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  14. Change in glycaemic risk measured with low blood glucose index (LBGI) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
    Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers.

  15. Change in glycaemic risk measured with high blood glucose index (HBGI) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
    High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers.

  16. Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) (mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  17. Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) (mmol/l) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  18. Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2) (mg/dl) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  19. Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2) (mmol/l) [ Time Frame: Comparison of the run-in period (2 week period) vs the intervention period (6 week period) ]
  20. Measurement of satisfaction of diabetes treatment using Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: DTSQ will be completed in the first and the last visit of the study in each phase (8 week period). ]
  21. Measurement of quality of life in patients with diabetes mellitus using Diabetes Quality of Life (DQOL) questionnaire. [ Time Frame: DQOL questionnaire will be completed in the first and the last visit of the study in each phase (8 week period). ]
  22. Measurement of diabetes related problems by using Problem Areas in Diabetes (PAID) questionnaire [ Time Frame: PAID questionnaire will be completed in the first and the last visit of the study in each phase (8 week period). ]
  23. Evaluation of usability and the treatment satisfaction of PEPPER system by using non-validated questionnaires. [ Time Frame: Questionnaires will be completed an average 1 time per week through each phase (8 week period). ]
    These questionnaires ask about ability to perform a number of tasks with a mobile device. Usability assessment has been incorporated into the clinical study visits for each clinical study phase.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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 Clarke 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186300


Locations
Layout table for location information
Spain
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Spain, 17007
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Imperial College London
Oxford Brookes University
University of Girona
Cellnovo Limited
Romsoft SRL
Investigators
Layout table for investigator information
Principal Investigator: José Manuel Fernández Real Institut d'Investigació Biomèdica de Girona (IDIBGI) Unitat de Diabetis, Endocrinologia i Nutrició de Girona (UDENG) Hospital Universitari de Girona Dr Josep Trueta
Principal Investigator: Mercè Fernández-Balsells Institut d'Investigació Biomèdica de Girona (IDIBGI) Unitat de Diabetis, Endocrinologia i Nutrició de Girona (UDENG) Hospital Universitari de Girona Dr Josep Trueta
Principal Investigator: Nick Oliver Imperial Collage London

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Last version of the study protocol submitted to the Spanish regulatory agency.

Publications of Results:

Layout table for additonal information
Responsible Party: José Manuel Fernández-Real, Principal Investigator, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT03186300     History of Changes
Other Study ID Numbers: 599/16/EC
689810 ( Other Grant/Funding Number: European Union´s Horizon 2020 Research and Innovation Programme )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José Manuel Fernández-Real, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
bolus advisor

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases