Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial
Primary result · HbA1cResult — go to the resultBetween-group difference 0.24 %Authors' conclusion
POWER2DM improves HbA1c levels compared with usual care in those with type 2 diabetes, improves QoL in those with type 1 diabetes, improves diabetes self-management in those with type 1 and type 2 diabetes, and is well accepted in daily life.
Study context
- Population
- Adults (>18 years) with T1D or T2D from hospital outpatient diabetes clinics in the Netherlands and Spain108 T1D
- Participants
- 226 adults
- Comparison
- POWER2DM integrated e-health system vs usual care
- POWER2DMn = 111
- Usual caren = 115reference
- Primary endpoint
- Change in HbA1c between groups
- Follow-up
- 37 weeks
Methodological detailsopen-label (participants and clinicians not blinded), multicentre (Netherlands and Spain)
- Open-label (participants and clinicians not blinded)
- Multicentre (Netherlands and Spain)
Primary result
HbA1c
Between-group difference
0.24 %
P = 0.008
By group
As reported in the abstract
Secondary outcomes
| Outcome | P value |
|---|---|
| QoL (WHO-5), T1D subgroup · 37 weeksQoL improved with POWER2DM · sub-analysis | P = 0.047 for between-group difference |
HbA1c, T2D subgroup within POWER2DM · 37 weeks
- HbA1c decreased from 62.3±17.3 mmol/mol (7.9±1.6%) to 54.3±11.1 mmol/mol (7.1±1.0%)
- P < 0.001
- Sub-analysis
HbA1c, T1D subgroup within POWER2DM · 37 weeks
- No change in HbA1c: baseline 58.8±11.2 mmol/mol [7.5±1.0%]; end of study 59.2±12.7 mmol/mol [7.6±1.2%]
- P = 0.84
- Sub-analysis
CGM glucose 3.0–3.9 mmol/l and clinically relevant hypoglycaemia (<3.0 mmol/l)
- Increased time with interstitial glucose between 3.0 and 3.9 mmol/l with POWER2DM, but no increase in clinically relevant hypoglycaemia (<3.0 mmol/l)
Quality of life (QoL) (WHO-5), T1D subgroup · 37 weeks
- WHO-5 baseline 15.7±3.8; end of study 16.3±3.5
Diabetes self-management (DSMQ-R) within POWER2DM · 37 weeks
- T1D: from 7.3±1.2 to 7.7±1.2
- P = 0.002
- T2D: from 6.5±1.3 to 6.7±1.3
- P = 0.003
- Sub-analysis
Technology acceptance
- POWER2DM was well accepted in daily life
Safety
- No important adverse (or unexpected) effects or side effects observed
Original publication
Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial. Diabetologia. Published 29 September 2023. doi:10.
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