Trial Outcomes & Findings for Hypoglycemia (Low Blood Sugar) and the Heart (NCT NCT01980914)

NCT ID: NCT01980914

Last Updated: 2020-03-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

6 days

Results posted on

2020-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Diabetic Patients 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
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only 11 participants were enrolled, 1 withdrew due to skin irritation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic Patients n=11 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants • Only 11 participants were enrolled, 1 withdrew due to skin irritation.
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants • Only 11 participants were enrolled, 1 withdrew due to skin irritation.
Age, Categorical >=65 years	11 Participants n=5 Participants • Only 11 participants were enrolled, 1 withdrew due to skin irritation.
Age, Continuous	80.4 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants • Only 11 participants were enrolled, 1 withdrew due to skin irritation.
Sex: Female, Male Male	7 Participants n=5 Participants • Only 11 participants were enrolled, 1 withdrew due to skin irritation.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	11 Participants n=5 Participants
Subjects with type 2 diabetes over age 70	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 days

Population: Only participants who completed the study were analyzed

Outcome measures

Outcome measures
Measure	Diabetic Patients n=11 Participants 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 withdrew after 24 hours due to skin irritation. 10 subjects have completed study.
Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl	11 Participants

SECONDARY outcome

Timeframe: 6 days

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

Outcome measures

Outcome measures
Measure	Diabetic Patients n=11 Participants 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 withdrew after 24 hours due to skin irritation. 10 subjects have completed study.
Alteration in Cardiac Rhythm	11 Participants

Adverse Events

Diabetic Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diabetic Patients n=11 participants at risk 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 withdrew after 24 hours due to skin irritation. 10 subjects have completed study.
Skin and subcutaneous tissue disorders Skin irritation	9.1% 1/11 • Number of events 1 • Adverse event date were collected during study period of up to 7 days when glucose sensors were attached.

Additional Information

Boris Feldman

Gerontology Research Unit

Phone: 6048755115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place