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DiaGame: Serious and personalized game for selfmanagement of diabetes

DiaGame: Serious and personalized game for selfmanagement of diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25562
Enrollment
220
Registered
2021-02-05
Start date
2021-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Diabetes mellitus

Interventions

Registration of daily life by continu glucose monitoring with a Freestyle Libre Pro sensor (Abbott) and exercise, nutrition, medication and mental status by Gamebus app and smartwatch

Sponsors

Prof dr H. Haak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Informed consent obtained before trial related activities • 20 patients with type 1 diabetes mellitus and BMI < 30 • 200 patients with type 2 diabetes mellitus • Age above 18 years • Patient’s language skills are sufficient for participation • Subject has a smartphone and is willing to install the needed apps on it.

Exclusion criteria

Exclusion criteria: • Pregnancy of breastfeeding women • Scheduled scan or MRI at time of wearing freestyle libre pro sensor • Malignancy excepted basal and squamous cell skin cancer

Design outcomes

Primary

MeasureTime frame
To collect patient gathered health data (PGHD) that is needed for the development of SugarVita. This includes glucose levels from patients with diabetes and information regarding different factors (physical activity, nutrition, medication and mental state) that can influence those levels. Also the HbA1c, C peptide and HOMA-IR index will be used as a clinical measure of glycemic control and insulin resistance and will be used as an outcome measure to determine the effect of playing SugarVita.

Contacts

Public ContactPleun Wouters- van Poppel

Maxima Medical Center

pleun.wouters@mmc.nl0408886300

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)