Adjustment of the dose of long acting insulin (Degludec) to reduce low glucose after exercise in patients with type 1 diabetes

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes – the ADREM study - ADREM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004222-22-NL

Enrollment

Registered

2019-12-10

Start date

2020-02-13

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

type 1 diabetes mellitus

Interventions

Trade Name: Tresiba Product Name: Insulin Degludec Product Code: EU/1/12/807/001 Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adults with type 1 diabetes mellitus, 18-60 years • Diabetes duration at least two years • Treatment with long-acting insulin in combination with short-acting insulin analogue, according to basal-bolus regimen for at least one year • Stable glycaemic control with HbA1c =75 mmol/mol (9%) • At least one severe hypoglycaemia in the past year and/or =2 points on Dutch modified version of Clarke score or =3 points on Gold score • Regularly engaging in exercise of moderate intensity or more (at least one hour per week) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Microvascular complications, except background retinopathy or microalbuminuria • History of cardiovascular disease, including heart failure, symptomatic cardiac valve disease and treatment-requiring arrhythmia • Use of drugs affecting glucose metabolism other than insulin or metformin • BMI >30 kg/m2 • Blood pressure >160/90 mmHg or use of blood pressure lowering drugs • Pregnancy or the wish to become pregnant • MDRD-GFR <60 ml/min/1.73 m2

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of three degludec dosing regimens on the risk of post-exercise nocturnal hypoglycaemia (time spent in glucose range =3.8 mmol/l, 00:00 to 05:59h) in type 1 diabetes mellitus patients at elevated risk of hypoglycaemia.;Secondary Objective: To investigate the effect of three post-exercise degludec dosing regimens on: - Time spent in nocturnal hyperglycaemia - Number of nocturnal hypoglycaemic events - Number of serious hypoglycaemic events (in the 6 days following exercise) - Number of severe hypoglycaemic events (in the 14 days following exercise) - Total number of hypoglycaemic events (in the 6 days following exercise) ;Primary end point(s): Time spent in hypoglycaemic range (i.e. glucose =3.8 mmol/l) during the night (00:00 to 05:59h) following the exercise day measured by continuous glucose monitoring.;Timepoint(s) of evaluation of this end point: At the end of each treatment period	—

Measure

Time frame

Main Objective: To investigate the effect of three degludec dosing regimens on the risk of post-exercise nocturnal hypoglycaemia (time spent in glucose range =3.8 mmol/l, 00:00 to 05:59h) in type 1 diabetes mellitus patients at elevated risk of hypoglycaemia.;Secondary Objective: To investigate the effect of three post-exercise degludec dosing regimens on: - Time spent in nocturnal hyperglycaemia - Number of nocturnal hypoglycaemic events - Number of serious hypoglycaemic events (in the 6 days following exercise) - Number of severe hypoglycaemic events (in the 14 days following exercise) - Total number of hypoglycaemic events (in the 6 days following exercise) ;Primary end point(s): Time spent in hypoglycaemic range (i.e. glucose =3.8 mmol/l) during the night (00:00 to 05:59h) following the exercise day measured by continuous glucose monitoring.;Timepoint(s) of evaluation of this end point: At the end of each treatment period

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Secondary

Measure	Time frame
Secondary end point(s): • Time spent in hyperglycaemic range during the night (00:00 to 05:59h) following the exercise day measured by CGM • Number of nocturnal hypoglycaemic events during the night (00:00 to 05:59h) following the exercise day measured by CGM • Number of serious hypoglycaemic events during the 6 days following the exercise day measured by CGM • Number of severe hypoglycaemic events during the 14 days following the exercise day • Total number of hypoglycaemic events during the 6 days following the exercise day measured by CGM ;Timepoint(s) of evaluation of this end point: At the end of each treatment period	—

Measure

Time frame

Secondary end point(s): • Time spent in hyperglycaemic range during the night (00:00 to 05:59h) following the exercise day measured by CGM • Number of nocturnal hypoglycaemic events during the night (00:00 to 05:59h) following the exercise day measured by CGM • Number of serious hypoglycaemic events during the 6 days following the exercise day measured by CGM • Number of severe hypoglycaemic events during the 14 days following the exercise day • Total number of hypoglycaemic events during the 6 days following the exercise day measured by CGM ;Timepoint(s) of evaluation of this end point: At the end of each treatment period

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Countries

Netherlands

Contacts

Public Contactresearch physician

Radboud University Medical Center

evertine.abbink@radboudumc.nl+31243618819

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026