Hypoglycemia (Low Blood Sugar) and the Heart

NCT01980914 | Completed Results

• 2 other identifiers: H13-02734unfunded
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia; Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 days

Secondary Outcomes (1)

• Alteration in Cardiac Rhythm

  6 days

Study Arms (1)

Type 2 diabetes group

EXPERIMENTAL

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 %.

Device: iPro2 glucose sensor attachment

Interventions

iPro2 glucose sensor attachment DEVICE

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.

Also known as: Icentia CardioSTAT

Type 2 diabetes group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Icentia UK: collaborator

Study Sites (1)

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

Vancouver, British Columbia, V6M 1N7, Canada

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 2; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Boris Feldman
• Organization: Gerontology Research Unit

boris.feldman@vch.ca

6048755115

Study Officials

• Graydon S Meneilly, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: March 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)