CGM-driven personalized exercise medicine: exercise snacks to combat hyperglycemia in patients with type 2 diabetes mellitus or pre-diabetes

CGM-driven personalized exercise medicine: exercise snacks to combat hyperglycemia in patients with type 2 diabetes mellitus or pre-diabetes - CGM-EXERCISE-SNACK-STUDY 2024

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033149

Enrollment

Registered

2023-12-11

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

E11 R73.0

Interventions

Group 1: (CON) Control intervention: wearing of a CGM sensor with a blinded CGM-reader. Group 2: (i-snack) individualised exercise snacks: wearing of a CGM sensor in the unblinded mode and performance

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: pre diabetes (HbA1c 5,7 - 6,4), type 2 diabetes mellitus (HbA1c = 6,5%)

Exclusion criteria

Exclusion criteria: insulin therapy, heart failure (NYHA II-IV, LVEF = 55), coronary heart disease (CHD), heart arrhythmia that requires treatment, peripheral artery disease (PAD) Fontaine stage III and IV, any disease or condition that would limit the performance of exercise snacks (e.g. kidney disease, neurological disease), oncologic illness (< 5 Jahre), psychiatric illness and/or addiction, acute and chronic infections (HIV, hepatitis), change in eating behaviour (<4 weeks), uptake of an exercise program (<4 weeks), = 1x/week sport or exercise training, pregnancy

Design outcomes

Primary

Measure	Time frame
mean 24h glucose, postprandial glucose area under the curve (PPG AUC), rates of hyperglycaemia, time spent in hyperglycemia 27.01.26: Although multiple outcomes were initially considered of primary interest, power calculations were only performed for one predefined endpoint: time in individual hyperglycaemia. Therefore mean glucose and rates of hyperglycaemia were analysed as secondary outcomes to avoid multiple comparison problem increasing type I error. There is currently no standardised method for baseline calculations from 'free-living' CGM-data. New methods have been describes, e.g. calculating the 40th percentile of the previous 24h as baseline [doi: 10.3389/fnut.2023.1203899], yet this approach is based on data from healthy subjects and has not generally been established. Therefore, we did not calculate and report AUC.	—

Measure

Time frame

mean 24h glucose, postprandial glucose area under the curve (PPG AUC), rates of hyperglycaemia, time spent in hyperglycemia 27.01.26: Although multiple outcomes were initially considered of primary interest, power calculations were only performed for one predefined endpoint: time in individual hyperglycaemia. Therefore mean glucose and rates of hyperglycaemia were analysed as secondary outcomes to avoid multiple comparison problem increasing type I error. There is currently no standardised method for baseline calculations from 'free-living' CGM-data. New methods have been describes, e.g. calculating the 40th percentile of the previous 24h as baseline [doi: 10.3389/fnut.2023.1203899], yet this approach is based on data from healthy subjects and has not generally been established. Therefore, we did not calculate and report AUC.

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Secondary

Measure	Time frame
Time in Range (TiR), Time above Range (TaR), Time below Range (TbR), rates of hypoglycaemia, qualitative data about the feasibility of performing exercise snacks in everyday life, activity profile and sitting time 27.01.26: Secondary outcomes: the rate of individual hyperglycaemic excursions, the percentage of time in 70–180 mg/dl range (TIR70-180), the percentage of time in 70–140 mg/dl tight range (TITR70-140), the percentage of time above 180 mg/dl (TAR>180), the percentage of time above 140 mg/dl (TATR>140), mean glucose (mg/dl) and the number of hypoglycaemic events. All CGM parameters were assessed using 72h recordings per intervention.	—

Measure

Time frame

Time in Range (TiR), Time above Range (TaR), Time below Range (TbR), rates of hypoglycaemia, qualitative data about the feasibility of performing exercise snacks in everyday life, activity profile and sitting time 27.01.26: Secondary outcomes: the rate of individual hyperglycaemic excursions, the percentage of time in 70–180 mg/dl range (TIR70-180), the percentage of time in 70–140 mg/dl tight range (TITR70-140), the percentage of time above 180 mg/dl (TAR>180), the percentage of time above 140 mg/dl (TATR>140), mean glucose (mg/dl) and the number of hypoglycaemic events. All CGM parameters were assessed using 72h recordings per intervention.

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Countries

Germany

Contacts

Public ContactKatharina Gross

Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. 1

kgross7@smail.uni-koeln.de+49 17645960625

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026