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Hypoglycemia (Low Blood Sugar) and the Heart

Primary Purpose

Hypoglycemia, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iPro2 glucose sensor attachment
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoglycemia focused on measuring hypoglycemia, type 2 diabetes, insulin glargine, cardiac function, myocardial ischemia, cardiac rhythm, autonomic cardiovascular function

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vancouver Coastal Health Research Institute (VCHRI/VCHA) site -Vancouver General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Type 2 diabetes group

Arm Description

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 %.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2013
Last Updated
February 28, 2020
Sponsor
University of British Columbia
Collaborators
icentia
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1. Study Identification

Unique Protocol Identification Number
NCT01980914
Brief Title
Hypoglycemia (Low Blood Sugar) and the Heart
Official Title
Impact of Hypoglycemia on Cardiac Function in Elderly Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
icentia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Type 2 Diabetes
Keywords
hypoglycemia, type 2 diabetes, insulin glargine, cardiac function, myocardial ischemia, cardiac rhythm, autonomic cardiovascular function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 diabetes group
Arm Type
Experimental
Arm Description
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 %.
Intervention Type
Device
Intervention Name(s)
iPro2 glucose sensor attachment
Other Intervention Name(s)
Icentia CardioSTAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl
Description
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
Secondary Outcome Measure Information:
Title
Alteration in Cardiac Rhythm
Description
To determine if there is a correlation between hypoglycemia and cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia.
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graydon S Meneilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Coastal Health Research Institute (VCHRI/VCHA) site -Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6M 1N7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypoglycemia (Low Blood Sugar) and the Heart

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