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

Phase 4

Completed

• Conditions: 10018424; Type 1 diabetes mellitus (lekenterm idem)

• Registration Number: NL-OMON48464
• Lead Sponsor: Afdeling Interne Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time spent in hypoglycaemic range (i.e. glucose <= 3.8 mmol/l) during the night<br /><br>(00:00 to 05:59h) following the exercise day measured by CGM </p><br>