Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study. (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: NCT03849755
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2019
Last Update Posted : February 21, 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 objective is to demonstrate safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.

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)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PEPPER study is a randomized cross-over clinical trial with 50 participants. After 4 weeks of ruin-in period all subjects will be randomized to either control group or intervention group in 1:1 ratio. The groups will be stratified by pump or MDI. After 3 months, each group will revert to their standard therapy for 4 weeks (wash-out period) and then crossover to the other group. All participants will be using CGM during whole study.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
PEPPER/Control
Group with intervention applied (PEPPER system) during the first three months and then, after wash -out period, swap to control group (using standard bolus calculator) for the next 3 months.
Device: PEPPER system
The PEPPER system offers insulin dosing advice that is highly adaptive to the insulin needs of individuals by using Case-Base Reasoning (CBR) approach.

Control/PEPPER
Group without intervention applied (using standard bolus calculator) during the first three months and then, after wash -out period, swap to intervention group (using PEPPER system) for the next 3 months.
Device: PEPPER system
The PEPPER system offers insulin dosing advice that is highly adaptive to the insulin needs of individuals by using Case-Base Reasoning (CBR) approach.




Primary Outcome Measures :
  1. Change in the percentage of time in glucose target range (glucose levels 3.9-10 mmol/l or 70 - 180 mg/dl) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in glycosylated hemoglobin (HbA1c) value [ Time Frame: 6 months ]
    Glycosylated hemoglobin (HbA1c) in % or mmol/mol

  2. 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: 6 months ]
  3. 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: 6 months ]
  4. Change in the percentage of time in hyperglycaemia (glucose level above 10 mmol/l or 180 mg/dl) [ Time Frame: 6 months ]
  5. Change in the percentage of time in hypoglycaemia (glucose level below 3, 9 mmol/L or 70 mg/dl) [ Time Frame: 6 months ]
  6. Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours [ Time Frame: 6 months ]
    measured in min x mg/dl

  7. Change in the post-prandial area under the curve (AUC) of glucose level at 6 hours [ Time Frame: 6 months ]
    measured in min x mg/dl

  8. Change in the post-prandial area under the curve (AUC) (< 3,9 mmol/l or <70 mg/dl) of glucose level at 4 hours [ Time Frame: 6 months ]
    measured in min x mg/dl

  9. Change in the post-prandial area under the curve (AUC) (< 3,9 mmol/l or <70 mg/dl) of glucose level at 6 hours [ Time Frame: 6 months ]
    measured in min x mg/dl

  10. Change in glycaemic risk measured with low blood glucose index (LBGI) [ Time Frame: 6 months ]
    Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers

  11. Change in glycaemic risk measured with high blood glucose index (HBGI) [ Time Frame: 6 months ]
    High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers

  12. Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) [ Time Frame: 6 months ]
    measured in mg/dl

  13. Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2) [ Time Frame: 6 months ]
    measured in mg/dl

  14. Change in weight (kg) [ Time Frame: 6 months ]
  15. Change in insulin dose requirements [ Time Frame: 6 months ]
    measured in in non-negative numbers

  16. Measurement of satisfaction of diabetes treatment using Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: 6 months ]

    The DTSQ s (status version) and DTSQ c (change version) contain eight items each, six of them (questions 1 and 4-8) measure the Treatment Satisfaction and questions 2 and 3, concerning Perceived Frequency of Hyperglycaemia ('Perceived Hyperglycaemia')/Perceived Frequency of Hypoglycaemia ('Perceived Hypoglycaemia') respectively, are treated separately from the satisfaction items and from each other.

    DTSQs scores range from 6 = very satisfied to 0 = very dissatisfied and DTSQc scores from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change.


  17. Measurement of quality of life in patients with diabetes mellitus using Diabetes Quality of Life (DQOL) questionnaire [ Time Frame: 6 months ]

    The instrument provides an overall scale score, as well as four subscale scores for

    1. satisfaction with treatment (with a range of 1-very satisfied to 5 -nothing satisfied) (overall results ranging from 15 to 75)
    2. impact of treatment (with a range of 1-never to 5 -always; minimum score 17, maximum 85)
    3. worry about social/vocational issues (with a range of 1-never to 5 -always; minimum score 7, maximum 35)
    4. worry about the future effects of diabetes (with a range of 1-never to 5 -always; minimum score 4, maximum 20)

  18. Measurement of diabetes related problems by using Problem Areas in Diabetes (PAID) questionnaire [ Time Frame: 6 months ]
    The Problem in Areas In Diabetes (PAID) is a questionnaire with 20 items in which responders are asked to indicate the degree to which each of the items is currently a problem for them, from 0 (not a problem) to 4 (a serious problem). The points of the scores for each item are summed , then multiplied by 1.25 to generate a total score out of 100. A total score of 40 and above indicates severe diabetes distress. A minimum score of 0 indicates no diabetes-related distress. Individual items score 3 or 4: moderate to severe distress; to be discussed during the consultation following completion of the questionnaire.

  19. Measurement of health-related quality of life by using EQ-5D questionnaire [ Time Frame: 6 months ]
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.

  20. Number of incidence of low glucose alarms [ Time Frame: 6 months ]
  21. Number of incidence of high glucose alarms [ Time Frame: 6 months ]
  22. Number of incidence of carbohydrate recommender [ Time Frame: 6 months ]
  23. Number of incidence of low glucose suspend [ Time Frame: 6 months ]
  24. Number of incidence of fault detection alarm [ Time Frame: 6 months ]
  25. Number of technical faults of the PEPPER safety system (any of the components listed above) [ Time Frame: 6 months ]
  26. Evaluation of usability of PEPPER system by conducting the usability test [ Time Frame: 6 months ]

    Participants are asked to solve 12 tasks by using PEPPER application. The difficulty of the task is evaluated from 0 till 3:

    0 = User completed task with zero difficulty. (Zero Frustration)

    1. = User completed task with only minor problem(s). (Little Frustration)
    2. = User completed task, but it required more effort/time/dead-ends than the user expected. (Medium/High Frustration)
    3. = User did not complete task. (Point of Failure)



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 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

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): NCT03849755


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

Publications:

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: NCT03849755     History of Changes
Other Study ID Numbers: 669/18/EC
689810 ( Other Grant/Funding Number: European Union´s Horizon 2020 Research and Innovation Programme )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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