Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-24 @ 9:31 PM
Study NCT ID:
NCT03588104
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2018-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"POWER2DM Evaluation Campaign"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic randomised trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glycemic control', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Change in HbA1c before and after the intervention compared between the intervention and control group'}], 'secondaryOutcomes': [{'measure': 'Amount hypoglycemia', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Amount of hypoglycemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group'}, {'measure': 'Hypo unawareness', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': "Hypo unawareness as measured by Clarke's hypo unawareness questionnaire, before and after treatment in the Power2DM group compared to the usual care control group"}, {'measure': 'Incidence of adverse events', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Incidence of adverse events occurring during the study period including serious hypoglycemic events'}, {'measure': 'Mean blood glucose (MBG)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a flash glucose monitoring (FGM) device'}, {'measure': 'Standard deviation of MBG (SDBG)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a FGM device'}, {'measure': 'Largest amplitude of glycemic excursions (LAGE)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a FGM device'}, {'measure': 'Mean amplitude of glycemic excursions (MAGE)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a FGM device'}, {'measure': 'Absolute means of daily differences (MODD)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a FGM device'}, {'measure': 'Time spent in range', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'As derived from continuous glucose measurements by a FGM device'}, {'measure': 'ADVANCE Cardiovascular risk', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The ADVANCE Cardiovascular Risk Engine, calculates the risk of major cardiovascular disease in patients with type 2 diabetes for the next 4 years (range 0-100%). This is defined as fatal or non-fatal myocardial infarction, stroke or cardiovascular death.'}, {'measure': 'ADVANCE Kidney disease Risk', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The ADVANCE Kidney Risk Engine, calculates the risk of new-onset albuminuria and major kidney-related events in patients with type 2 diabetes for the next 5 years (range 0-100%). Major kidney-related events are defined as doubling of serum creatinin to \\>2.26mg/dL, renal replacement therapy, or renal death.'}, {'measure': 'Major Outcomes T1D', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The Major Outcomes T1D risk score assess the 3, 5 and 7 year risk of a patient with type 1 diabetes on major outcomes (range 0-100%). These outcomes included major coronary heart disease, stroke, end-stage renal failure, amputations, blindness and all-cause death.'}, {'measure': 'UKPDS risk score', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The UKPDS risk score calculated the risk a patient with type 2 diabetes will develop coronary heart disease, fatal coronary hear disease, stroke or fatal stroke (range 0-100%)'}, {'measure': 'Q score', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The Q score is a single metric for a continuous glucose monitoring (CGM) profile which summarize the glucose profile using five factors: central tendency, hyperglycemia, hypoglycemia, intra- and inter daily variations.'}, {'measure': 'Amount of steps', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Average amount of steps per day over a week measured by a step counter'}, {'measure': 'Self-reported exercise time', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Exercise time per week as reported in the POWER2DM system'}, {'measure': 'Frequency of self-monitoring of blood glucose (SMBG) measurements', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Frequency of SMBG measurements as reported by the glucose measurement device'}, {'measure': 'Self-reported adherence to medication plan', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Self-reported adherence to medication plan as reported in the POWER2DM system'}, {'measure': 'Weight', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Weight in kilograms measured on a scale'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'BMI in kg/m2, computed from height and weight'}, {'measure': 'Diabetes Self-Management Questionnaire Revised (DSMQ-R)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'Subscales: Glucose Management, Dietary Control, Physical Activity, Health Care Use Transformed scale scores can vary between 0-10, with higher scores indicating more effective self-care'}, {'measure': 'Patient utilities by EQ-5D', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'No subscales: EQ-5D provides a general health index with higher scores indicating better general health. QALYs will be calculated from EQ-5D scores.'}, {'measure': 'Problem Areas in Diabetes (PAID)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The PAID provides a total diabetes distress score (0-100), with higher scores (\\> 40) indicating more distress.'}, {'measure': 'Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'WHO-5 provides a total score (0-100) with higher scores indicating better wellbeing, PHQ-9 provides a total score (1-27) indicating a likelihood of depression, with higher scores indicating more depressive symptoms'}, {'measure': 'Technology Acceptance Questionnaire (TAQ)', 'timeFrame': '5 weeks and 37 weeks', 'description': 'The TAQ provides scores (1-7) on the following domains: Performance expectancy, Effort expectancy, Social influence, Facilitating conditions, Affect, Self-efficacy, Trust, Motivation and Behavioural intention. Higher scores indicate better acceptance of the system.'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Over 37 weeks', 'description': 'Costs/quality adjusted life years (QALYs) Costs assessed via cost questionnaire and medication registry. QALYs based on patient utilities measured via EQ5D.'}, {'measure': 'Stress by perceived Stress Scale (PSS)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': 'The PSS provides a total perceived stress score (0-40), with higher scores indicating more perceived stress.'}, {'measure': 'Patient Assessment of Chronic Illness Care (PACIC)', 'timeFrame': '0 weeks, 11 weeks, 22 weeks and 37 weeks', 'description': "The PACIC measures the patient's perception of the care that they receive."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electronic Health (eHealth)'], 'conditions': ['Type1 Diabetes Mellitus', 'Type2 Diabetes Mellitus', 'Diabetes Mellitus', 'Health Behavior', 'Self Efficacy']}, 'referencesModule': {'references': [{'pmid': '37775611', 'type': 'DERIVED', 'citation': 'Ruissen MM, Torres-Pena JD, Uitbeijerse BS, Arenas de Larriva AP, Huisman SD, Namli T, Salzsieder E, Vogt L, Ploessnig M, van der Putte B, Merle A, Serra G, Rodriguez G, de Graaf AA, de Koning EJP, Delgado-Lista J, Sont JK; POWER2DM Consortium. Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial. Diabetologia. 2023 Dec;66(12):2213-2225. doi: 10.1007/s00125-023-06006-2. Epub 2023 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans.\n\nObjective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation.\n\nStudy design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks.\n\nStudy population: 230 patients with diabetes (N=115 type 1 diabetes (T1D), N=115 type 2 diabetes (T2D)) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115).\n\nIntervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry.\n\nMain study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed T2DM or T1DM\n* Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)\n\nExclusion Criteria:\n\n* Severe renal insufficiency (eGFR\\<30ml/min)\n* Serious/severe comorbidity that interferes with diabetes outcomes or diabetes self-management including but not limited to: psychiatric diseases, chronic hepatopathy, active malignancy, chronic obstructive pulmonary disease (COPD), disease of the digestive tract, endocrine disorders, cerebrovascular disease with disability\n* For female participants: pregnancy or wanting to become pregnant in the coming 9 months\n* Concurrent participation in other clinical trials\n* Any other situation in which the investigator identifies a potential risk of not being able to perform the study.'}, 'identificationModule': {'nctId': 'NCT03588104', 'acronym': 'POWER2DMEC', 'briefTitle': '"POWER2DM Evaluation Campaign"', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes', 'orgStudyIdInfo': {'id': 'P17.280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POWER2DM support group', 'description': 'Participants in this group will receive access to the POWER2DM system as an adjunct to usual care. The participants have three intervention visits in which they will use the Shared Decision Making Dashboard to set self-management goals and will use the Self-Management Support system for trying to reach those goals in the periods after the intervention visits.', 'interventionNames': ['Device: POWER2DM system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care group', 'description': 'Participants in this group will follow their usual diabetes care with their own diabetes care team.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'POWER2DM system', 'type': 'DEVICE', 'description': 'This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Power2DM support will be provided as an adjunct to usual care', 'armGroupLabels': ['POWER2DM support group']}, {'name': 'Usual care', 'type': 'OTHER', 'description': "Usual care as given to diabetes patients by the patient's diabetes care team.", 'armGroupLabels': ['Usual care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University Medical Centre', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Reina Sofia University Hospital', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Jacob Sont, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}, {'name': 'Javier Delgado Lista, MD Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andaluz Health Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Andaluz Health Service', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, associate professor', 'investigatorFullName': 'JKSont', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}