Using Glucose Sensors to Prevent Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such a situation may carry risks that the patient may harm him or her self. Medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may be worn or left close by eg on a bedside table. The device may be programmed to alarm for a rapidly falling glucose or for low glucose levels.

We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better HYPO score.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

NCT01178476

Type 1 Diabetes

WITHDRAWN NA

Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

NCT00494078

Critical Illness

COMPLETED NA

The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow

NCT02146404

Type 1 Diabetes Mellitus Hypoglycemia Unawareness

COMPLETED NA

Effect of Fasting on Insulin-induced Hypoglycemia Counterregulation in Healthy Humans

NCT04392843

Hypoglycemia

COMPLETED NA

Effect of Different Plasma Insulin Levels on the Accuracy of Continuous Subcutaneous Glucose Monitoring

NCT01714895

Type 1 Diabetes Continuous Glucose Monitoring Hypoglycemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative), with a HYPO score over the seventy-fifth percentile (\>423), will be approached and offered the study.

The study will be conducted over a three month time-frame. The first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. These records will be used to calculate the baseline modified HYPO score. Patients will be screened during the first month for thyroid disease, celiac disease and Addison's disease.

During the second month they will meet with the study nurse for an intensive instruction period on the use of the Paradigm RT sensor. They will spend this month practicing to use the sensor and confirming they can use it adequately.

During the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified HYPO score.

The end point will be the change from the baseline modified HYPO score to the final four week HYPO score and this would be used to identify any improvement.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Run in period

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Group Type EXPERIMENTAL

Use of glucose sensor (Paradigm Guardian)

Intervention Type DEVICE

Use glucose sensor to prevent episodes of severe hypoglycemia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Use of glucose sensor (Paradigm Guardian)

Use glucose sensor to prevent episodes of severe hypoglycemia

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paradigm Guardian glucose sensor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 1 Diabetes Mellitus confirmed by C-peptide \<0.10 nmol/L
* age 18 - 70 yrs.
* HYPO score \>423
* normal TSH, serum cortisol and anti-transglutaminase (ATTG)