Summary: In adults with type 1 or type 2 diabetes, a secondary analysis of the manufacturer-sponsored mySugr PRO randomised trial (n=342) found that use of a digital diabetes logbook nearly doubled the odds of reaching HbA1c 6.5% or below at 3 months (OR 2.24, 95% CI 1.12 to 4.47, P=.02). Propensity-matched real-world data (n=2861) showed associated mean blood glucose reductions of 16 to 27 mg/dL at 3 months and 19.8 mg/dL at 12 months, largest in those with the highest baseline HbA1c.
PICO Summary
| Element | Detail |
|---|---|
| Population | Adults with type 1 or type 2 diabetes. Randomised arm n=342 (mySugr PRO-RCT, German Clinical Trials Register DRKS00022923); propensity-matched real-world cohort n=2861, with a 12-month subcohort of n=1176. Secondary analysis of an open-label RCT enriched by observational real-world data. |
| Intervention | Use of the mySugr digital diabetes logbook app for self-management over 3 to 12 months (RCT intervention arm and real-world app users). |
| Comparison | RCT control arm receiving usual care without the digital logbook; within the real-world cohort, each participant served as their own pre-app baseline. |
| Outcome | Randomised primary outcome: odds of achieving HbA1c 6.5% or below at 3 months nearly doubled with the logbook (OR 2.24, 95% CI 1.12 to 4.47, P=.02; baseline HbA1c adjusted). Real-world (associational) outcomes: mean blood glucose fell by 16.3 mg/dL in type 1 (95% CI 20.6 to 12.4; P<.001) and 27.3 mg/dL in type 2 (95% CI 28.7 to 25.9; P<.001) over 3 months. The largest reductions occurred in those with baseline HbA1c above 8.5% (type 1 82.2 mg/dL; type 2 104.6 mg/dL). A 12-month decrease of 19.8 mg/dL (95% CI 21.8 to 17.9; P<.001) was sustained in the total real-world sample. No ARR or NNT was reported; harms were not assessed. |
Digital diabetes logbook and glycaemic control
RCT (secondary analysis) · type 1 or type 2 diabetes · 3 months
In the randomised arm, the digital logbook roughly doubled the odds of reaching HbA1c 6.5% or below at 3 months (OR 2.24, 95% CI 1.12 to 4.47). The large real-world glucose reductions are associational and likely overstate the effect.
Expert Commentary
The randomised component offers the more defensible signal: adjusted for baseline HbA1c, logbook users had roughly twice the odds of reaching an HbA1c of 6.5% or below at 3 months, and the confidence interval excludes no effect, albeit narrowly. The verdict is therefore a qualified positive for short-term glycaemic benefit, not a demonstration of durable, hard-outcome improvement. Several cautions are warranted. The trial was open-label, since a self-tracking app cannot be blinded, so engagement and expectation effects are difficult to separate from the tool itself. The study was sponsored by the app manufacturer, with several authors employed by mySugr and Roche, which raises the possibility of favourable framing. Most importantly, the large mean-glucose reductions come from observational, real-world data with each user acting as their own historical control; these are associations, not causal effects, and are vulnerable to regression to the mean, which is consistent with the exaggerated improvements seen in those with the highest baseline HbA1c. Harms, dropout, and sustained app use were not characterised in the abstract. Can I use this with my patients? Cautiously yes, for a motivated person with type 1 or type 2 diabetes and an elevated HbA1c who is willing to self-track, while being candid that the strong real-world numbers overstate what a logbook alone will deliver. I would welcome an independent, longer, blinded-endpoint trial reporting HbA1c rather than estimated glucose before treating this as established.
References
Ehrmann D, Ruch B, Mitter M, Kober J, Hermanns N, Schäfer V, Kulzer B, Silbermann S. Improvements in Glycemic Control With a Digital Diabetes Logbook: Secondary Analysis of a Randomized Controlled Trial Enriched by Observational, Real-World Data. J Med Internet Res. 2025;27:e68933. doi:10.2196/68933