Skip to content

Hypoglycemia (Low Blood Sugar) and the Heart

Impact of Hypoglycemia on Cardiac Function in Elderly Patients With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01980914
Enrollment
11
Registered
2013-11-11
Start date
2015-03-31
Completion date
2019-09-30
Last updated
2020-03-16

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

Conditions

Hypoglycemia, Type 2 Diabetes

Keywords

hypoglycemia, type 2 diabetes, insulin glargine, cardiac function, myocardial ischemia, cardiac rhythm, autonomic cardiovascular function

Brief 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.

Detailed description

Investigators propose a pilot study in 20 patients over age 70 who have type 2 diabetes and are being treated with insulin. These patients will be enrolled from the elderly diabetes clinic at Vancouver General Hospital. Patients will be asked to come to the Gerontology research laboratory in the Research Pavilion at Vancouver General Hospital. A trained research nurse will instrument each patient with an iPro2 glucose sensor (Medtronic Canada). These sensors reliably and continuously measure blood glucose for periods of up to 7 days. Briefly, the skin will be swabbed with a disinfectant and a small catheter will be inserted subcutaneously. This needle will be attached to a glucose sensor. Patients will wear this sensor for 6 days. Patients will measure their glucose using a glucometer 4 times each day during this period and will also be given a log book to keep track of glucose values. Patients will also be asked to record any symptoms of hypoglycemia. At the end of 6 days the sensor will be removed. At the same time the glucose sensor is started, a trained research nurse will connect the patient to a single use CardioSTAT ECG recorder. The archived ECG waveforms will be downloaded for QT and T-wave alternans analysis. The heart rate and QT interval will be measured at baseline and the end of each interval from the digitized ECG. Patients and relevant family will be provided with in person education regarding the function and use of the monitor, implications for bathing and sleep, and contact information for troubleshooting. Patients will be asked to change the leads at home twice during the 6 days of the study. Patients will be asked to keep a log book of any cardiac symptoms during the 6 days of the study, as well as their activities. The glucose and CardioSTAT monitor will undergo time synchronization to ensure ability to do correlative analysis. This is a feasibility pilot to establish preliminary data for analysis. The CardioSTAT monitor will allow assessment of cardiac arrhythmias, myocardial ischemia and cardiovascular autonomic function. The results from the glucose sensor and the CardioSTAT monitor will be correlated and compared to each other to determine if hypoglycemia has an adverse effect on heart function. Hypoglycemia is likely to induce autonomic responses captured on the CardioSTAT monitor and concordant ischemic S-T segment changes if coronary disease is present. It may also detect any resultant arrhythmias, although ischemic arrhythmias are uncommon in 6 days of monitoring. If investigators determine that hypoglycemia has negative effects on cardiac function, investigators may able to design treatments that would prevent these effects from happening in the future.

Interventions

DEVICEiPro2 glucose sensor attachment

At the same time the glucose sensor is started, a trained research nurse will connect the patient to an Icentia CardioSTAT, a continuous ambulatory ECG cardiac monitor.

Sponsors

Icentia UK
CollaboratorINDUSTRY
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

We propose a pilot study in 20 patients over age 70 who have had type 2 diabetes for at least 5 years and are being treated with insulin All patients will have a BMI of between 20 and 35 Kg/M2, and an A1C between 7 and 8.5 %. All patients will have well controlled hypertension and hyperlipidemia. Patients with a GFR less than 40ml/min, poorly controlled CHF and active coronary artery disease or cerebrovascular disease will be excluded, although a past history of CAD or stroke will not result in exclusion

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl6 daysTrack hypoglycemia with continuous glucose monitor. Subjects had measured their glucose using a glucometer 4 times each day during this period and were also got a log book to keep track of glucose values. They were also asked to record any symptoms of hypoglycemia. At the end of 6 days the sensor was removed.

Secondary

MeasureTime frameDescription
Alteration in Cardiac Rhythm6 daysTo determine if there is a correlation between hypoglycemia and cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Diabetic Patients
We are aim to recruit group of 20 diabetic patients with type 2 diabetes over age 70, who are being treated with insulin. However, only 11 patients were enrolled. 1 subject had experienced AE due to to skin irritation. 11 subjects have completed study.
11
Total11

Baseline characteristics

CharacteristicDiabetic Patients
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
11 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous80.4 years
STANDARD_DEVIATION 1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
Canada
11 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
7 Participants
Subjects with type 2 diabetes over age 7011 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 11
other
Total, other adverse events
1 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl

Track hypoglycemia with continuous glucose monitor. Subjects had measured their glucose using a glucometer 4 times each day during this period and were also got a log book to keep track of glucose values. They were also asked to record any symptoms of hypoglycemia. At the end of 6 days the sensor was removed.

Time frame: 6 days

Population: Only participants who completed the study were analyzed

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diabetic PatientsNumber of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl11 Participants
Secondary

Alteration in Cardiac Rhythm

To determine if there is a correlation between hypoglycemia and cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia.

Time frame: 6 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diabetic PatientsAlteration in Cardiac Rhythm11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026