Recurrent nocturnal hypoglycaemia after basal insulin increase and exercise programme
A pharmacovigilance case for causality assessment: work out which drug is responsible, grade the reaction's severity and seriousness, and defend a causality category using the WHO-UMC causality assessment.
WHO-UMC causality assessment
- Framework
- WHO-UMC causality assessment
- You decide
- Suspect drug, reaction, severity, seriousness, causality
The case
Mrs. Smith, a 30-year-old woman with type 1 diabetes mellitus for 12 years, presents to the diabetes clinic with a three-week history of recurrent nocturnal hypoglycaemia. She reports waking at approximately 3 am with sweating, palpitations, and confusion. Capillary blood glucose measured on these occasions has been between 2.4 and 3.0 mmol/L. She treats these episodes with oral glucose.
Medication history: She has been on a stable insulin regimen for the past year, comprising insulin glargine (Lantus) 20 units subcutaneously once daily at bedtime, insulin lispro (Humalog) 6 units before breakfast, 8 units before lunch, and 6 units before dinner. She also takes levothyroxine 50 mcg once daily for hypothyroidism.
Two months ago, she started a jogging programme, jogging for 30 minutes in the evening, three times a week. One month later, her HbA1c was 8.2%, and her insulin glargine was increased to 24 units once daily. The nocturnal hypoglycaemic episodes began three days after the dose increase, occurring two to three times per week. Her clinician reduced the insulin glargine back to 20 units after one week. The hypoglycaemic episodes resolved within two days of the dose reduction and did not recur during the following two weeks. She later mistakenly took 24 units for two nights (thinking she was still on the higher dose) and the nocturnal hypoglycaemia recurred.
On examination during an episode, she was pale and sweaty with a heart rate of 110 bpm. Between episodes, physical examination was unremarkable. Recent HbA1c after the dose reduction was 7.8%. Thyroid function tests were normal. The patient did not change her exercise schedule during the dose increase or reduction.
What you are asked to do
- Identify which of the patient's drugs is the suspect, and say why the others are not.
- Name the reaction and grade its severity.
- Decide whether it is serious by regulatory criteria, which is not the same as severe.
- Assign a causality category under the WHO-UMC causality assessment and justify it from the timeline, the dechallenge and the alternative causes.
- State the management and what should be reported.
The suspect drug and the graded answer are deliberately not on this page: working them out is the exercise.
Log in to assess "Recurrent nocturnal hypoglycaemia after basal insulin increase and exercise programme"
A free account opens the trainer: name the suspect drug, grade the reaction and commit to a causality category, then see how your assessment compares and why.
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Educational content for students and clinicians in training. It does not replace professional judgement, local protocols or current prescribing information.