Evaluation of the POWER2DM Diabetes Self-Management Support System compared with usual care for patients with diabetes

Evaluation of the POWER2DM Diabetes Self-Management Support System compared with usual care for patients with diabetes - POWER2DM Evaluation Campaign

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46363

Enrollment

115

Registered

2018-05-25

Start date

2018-12-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'Diabetes Mellitus' 'Diabetes'

Interventions

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-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diabetes type 1 or Diabetes type 2 Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher) In possession of a smartphone that can run the POWER2DM mobile application

Exclusion criteria

Exclusion criteria: Severe renal insufficiency (eGFR

Design outcomes

Primary

Measure	Time frame
Change in glucose regulation as measured by HbA1c before and after the intervention compared between the intervention and control groups.	—

Secondary

Measure	Time frame
• Safety As measured by: o amount of hypoglycaemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group, o 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 and o other adverse events occurring during the study period to include serious hypoglycemic events among others • Glucose variability As derived from continuous measurements and defined as measured by: o Mean blood glucose (MBG) o Standard deviation of MBG (SDBG) o Largest amplitude of glycemic excursions (LAGE) o Mean amplitude of glycemic excursions (MAGE) o Absolute means of daily differences (MODD) o Time spent in range • Model based risk scores o ADVANCE Cardiovascular risk o ADVANCE Kidney disease Risk o Major outcomes T1D o UKPDS risk score o MT2D-Marvel model o KADIS-based Q score • Behavioural change (self-management) o Exercise o Frequency of SMBG measurements o Adherence to medication plan o Amount of goals reached o Weight (and BMI) o Diabetes Self-Management score • Psycho-social changes o Quality of life o Diabetes burden o Mental health o Diabetes knowledge o Diabetes self-efficacy • User satisfaction o Satisfaction with diabetes care o Communication with healthcare provider o User feedback on SMSS o Goal Progress o Usage of app • Cost-effectiveness (socio-economic impact)	—

Measure

Time frame

• Safety As measured by: o amount of hypoglycaemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group, o 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 and o other adverse events occurring during the study period to include serious hypoglycemic events among others • Glucose variability As derived from continuous measurements and defined as measured by: o Mean blood glucose (MBG) o Standard deviation of MBG (SDBG) o Largest amplitude of glycemic excursions (LAGE) o Mean amplitude of glycemic excursions (MAGE) o Absolute means of daily differences (MODD) o Time spent in range • Model based risk scores o ADVANCE Cardiovascular risk o ADVANCE Kidney disease Risk o Major outcomes T1D o UKPDS risk score o MT2D-Marvel model o KADIS-based Q score • Behavioural change (self-management) o Exercise o Frequency of SMBG measurements o Adherence to medication plan o Amount of goals reached o Weight (and BMI) o Diabetes Self-Management score • Psycho-social changes o Quality of life o Diabetes burden o Mental health o Diabetes knowledge o Diabetes self-efficacy • User satisfaction o Satisfaction with diabetes care o Communication with healthcare provider o User feedback on SMSS o Goal Progress o Usage of app • Cost-effectiveness (socio-economic impact)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)