Change in HbA1c and CGM Metrics Following Hybrid Automated Insulin Delivery (AID) Therapy in Type 1 Diabetes Mellitus

Change in HbA1c and CGM Metrics Following Hybrid Automated Insulin Delivery (AID) Therapy in Type 1 Diabetes Mellitus - AID in North Germany (AIDiNG)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040685

Enrollment

250

Registered

2026-06-22

Start date

2025-09-10

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

E10

Interventions

Group 1: Treatment with one of the automated insulin delivery (AID) systems approved for use in Germany

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of type 1 diabetes mellitus Transition to AID system

Exclusion criteria

Exclusion criteria: other types of diabetes

Design outcomes

Primary

Measure	Time frame
Change in HbA1c (lab parameter) from AID initiation to 12 months after therapy initiation.	—

Secondary

Measure	Time frame
Change in CGM-derived metrics from baseline (AID initiation) to 12 months after initiation of AID therapy: - Percentage of time with glucose values within the target range (70–180 mg/dL); Time in Range (TIR) - Percentage of time below the target range (180 mg/dL); Time Above Range (TAR) - Percentage of time in Level 1 hyperglycemia (181–250 mg/dL); TAR1 - Percentage of time in Level 2 hyperglycemia (>250 mg/dL); TAR2 HbA1c values at 3, 6, and 9 months after AID initiation and ervery 3 months up until 24 months of follow up. Differences in ?HbA1c (12 months vs. baseline) between AID systems Predictors of improvement in glycemic control (?HbA1c)	—

Measure

Time frame

Change in CGM-derived metrics from baseline (AID initiation) to 12 months after initiation of AID therapy: - Percentage of time with glucose values within the target range (70–180 mg/dL); Time in Range (TIR) - Percentage of time below the target range (180 mg/dL); Time Above Range (TAR) - Percentage of time in Level 1 hyperglycemia (181–250 mg/dL); TAR1 - Percentage of time in Level 2 hyperglycemia (>250 mg/dL); TAR2 HbA1c values at 3, 6, and 9 months after AID initiation and ervery 3 months up until 24 months of follow up. Differences in ?HbA1c (12 months vs. baseline) between AID systems Predictors of improvement in glycemic control (?HbA1c)

—

Countries

Germany

Contacts

Public ContactStephan Arndt

Diabendo Praxiszentrum Rostock

s.arndt@diabendo.org+49 381 2005669

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026