Glycemic ControlHybrid closed-loop system

Clinical evidence dossier

Hybrid closed-loop system

Time in range

Evidence signal

Evidence signal

Strong

This is an authoritative evidence signal supplied by Clinical Reference. It is not a formal clinical grade, treatment recommendation, or pooled effect estimate.

Evidence snapshot

Authoritative support records
17
Supporting studies available for review
17
Randomized trials
16
Reported effects
35

Clinical conclusion

Hybrid closed-loop system shows a moderate positive evidence signal for improving Time in range across the studied comparisons.

The conclusion and evidence-signal classification are distinct authoritative fields and are reproduced as published.

Observed effects

Observed study estimates; not a pooled treatment effect.

Change from baseline

Absolute change

61.2% to 61.2%

1 eligible estimates2–2 weeksObserved median: 61.2%

Between-group effect

Absolute change

−15.6% to 79.2%

3 eligible estimates2–12 weeksObserved median: 13.7%

Between-group effect

Absolute change

−15 percentage points to 15 percentage points

5 eligible estimates12–78 weeksObserved median: 8.4 percentage points

Between-group effect

Mean difference

−3.6% to 15.2%

4 eligible estimates2–8 weeksObserved median: −2.1%

Evidence composition

Non-randomized studies
0
Other designs
0
Unresolved designs
1
Magnitude-eligible effects
13

Consistency

Consistency classification

Mostly consistent

Positive
9
No effect
4
Mixed
4
Negative
0

Population and applicability

Structured population data were available for 17 of 17 supporting studies. Diabetes type was heterogeneous: 10 studies with type 1 diabetes, 2 studies with type 2 diabetes. Age groups were heterogeneous: 12 studies with adult participants, 1 studies with youth participants.

This population information refers to the materialized supporting studies available for review. Omitted support records remain part of the authoritative support accounting and are available through the audit experience.

View reported population descriptions

These descriptions are reported across the supporting studies; they are not a single synthesized population.

  • Adults aged 18 and older with type 1 diabetes.
  • Individuals currently managing diabetes with insulin therapy.
  • Participants starting advanced hybrid closed-loop therapy.
  • Young Adult (19–39)
  • Middle Aged (40-64)
  • Older Adults (65+)
  • Male
  • Female
  • with T1 Diabetes
  • Adults with diabetes and advanced chronic kidney disease.
  • Individuals requiring insulin therapy.
  • Women with Type 1 diabetes postpartum.

Limitations

  • 4 supporting studies do not have a displayable topic-matched quantitative effect.
  • Evidence uses heterogeneous comparison contexts: active_comparator, baseline_within_group, other, unknown_unresolved, usual_care.
  • 1 supporting study has high, serious, critical, unclear, or unavailable risk-of-bias information.
  • 1 study contains conflicting p-value and significance fields; those significance claims are suppressed.

Supporting evidence

Inspect the authoritative studies and omitted support records for this dossier.

View supporting evidence