N/A
N=11
Hypoglycemia (Low Blood Sugar) and the Heart
Hypoglycemia · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01980914 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iPro2 glucose sensor attachment (Device)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl |
11 | — |
| SECONDARY Alteration in Cardiac Rhythm |
11 | — |
Summary
The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes increases with age. Hypoglycemia is a common reason for admission to hospital for older patients with diabetes. Older patients are often unaware that their blood sugar is low and asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in the elderly. There is also evidence that older people with diabetes are more likely to develop cardiovascular events such a heart attack and more likely to die suddenly when compared to older people without diabetes. It is possible that low blood sugar levels contribute to the increased frequency of these events, but this possibility has never been studied. The purpose of this study is to assess how frequently low blood sugar occurs in older patients with diabetes and to see if low blood sugars adversely affect heart function in these patients.
Eligibility Criteria
Inclusion Criteria
- 70 years old and over
- had type 2 diabetes for at least 5 years
- treated with insulin glargine.
- BMI of between 20 and 35 Kg/M2,
- A1c between 7 and 8.5 %.
- well controlled hypertension and hyperlipidemia.
Exclusion Criteria
- cannot speak english or give informed consent, or cognitive impairment
- glomerular filtration rate (GFR) less than 40ml/min,
- poorly controlled Chronic Heart Failure
- active coronary artery disease
- active cerebrovascular disease although a past history of CAD or stroke will not results in exclusion.
Data sourced from ClinicalTrials.gov (NCT01980914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.