To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 CGM
Secondary outcome
- 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)
- Proportion of patients with at least 1 nocturnal hypoglycaemic event
- Proportion of patients with at least 1 serious hypoglycaemic event (in the 6
days following exercise)
- Proportion of patients with at least 1 severe hypoglycaemic event (in the 14
days following exercise)
- Proportion of patients with at least 1 hypoglycaemic event (in the 6 days
following exercise)
- Time spent in hypoglycaemia (in the 6 days following exercise)
- Time spent in serious hypoglycaemia (in the 6 days following exercise)
- Time in range (TIR, in the 6 days following exercise)
- Time spent in hyperglycaemia (in the 6 days following exercise)
- Next day fasting glucose
- Next day fasting ketones
- 7-point glucose profiles (in the 6 days following exercise)
- 24 and 48 hour glucose profiles
- Carbohydrate intake after exercise and the day following exercise
Background summary
It is common practice for people with type 1 diabetes mellitus (DM1) to reduce
the dose of long-acting insulin at bedtime after exercise to reduce the risk of
subsequent nocturnal hypoglycaemia . The new long-acting insulin analogue
insulin degludec has a flatter and more stable glucose-lowering profile than
conventional long-acting insulin, in large part due to the much longer
half-life of > 24 hours (twice as long as conventional insulin). It is not
known whether or not dosing adjustments for insulin degludec are to be
recommended after exercise to reduce the risk of nocturnal hypoglycaemia.
Study objective
To examine the effect of two different degludec dose adjustments on glucose
profiles and the incidence of (nocturnal) hypoglycaemia after oxidative
exercise in people with DM1 at elevated risk of hypoglycaemia.
Study design
Randomised controlled cross-over intervention study
Intervention
Randomised cross-over treatment with three degludec dosing regimens (1. No
adjustment of the degludec dose (control), 2. Reducing the dose of degludec by
40%, 3. Postponing the administration of degludec for 8 hours and reducing the
dose by 20%) after a 45-min exercise test on a bicycle ergometer followed by
blinded continuous glucose monitoring (CGM) during 6 days.
Study burden and risks
The study participants will not benefit directly from participation in this
clinical trial. Participants will visit the hospital for a screening visit, 3
long visits (6 hours) with an exercise test and 1 short visit (30 min). The
duration of the entire trial per patient is 10 weeks. Insulin degludec has a
generally favourable safety profile. In total 15 blood samples will be taken.
The total blood volume taken will be approximately 250 ml. During the screening
and the long visits an intravenous cannula will be inserted to limit the number
of venous punctures.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004222-22-NL |
| CCMO | NL71903.091.19 |