Dexcom G6 Intervention Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2021-02-27

Brief Summary

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The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).

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Detailed Description

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Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality.

Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if CGM represents a better tool to guide healthcare providers in adjusting insulin therapy by providing a more complete 24-hour assessment of glucose values compared to POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.

Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.

Group Type EXPERIMENTAL

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

Intervention Type DEVICE

A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.

POC BG - Point-of-Care Blood Glucose monitoring

Intervention Type DIAGNOSTIC_TEST

Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay up to 10 days.

POC BG - Point-of-Care Blood Glucose monitoring

Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded in the electronic medical record (EMR) system. The research team together with the PCP team will adjust daily insulin orders based on POC readings (standard of care). In addition, patients will wear a 'blinded' CGM where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams.

Group Type ACTIVE_COMPARATOR

POC BG - Point-of-Care Blood Glucose monitoring

Intervention Type DIAGNOSTIC_TEST

Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay up to 10 days.

Interventions

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Dexcom G6 CGM - Continues Glucose Monitoring sensor system

A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Intervention Type DEVICE

POC BG - Point-of-Care Blood Glucose monitoring

Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay up to 10 days.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Standard of Care capillary glucose test

Eligibility Criteria

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Inclusion Criteria

1. Males and females ≥ 18 years admitted to a general medicine or surgical services.
2. History of T1D or T2D receiving insulin therapy during hospital admission.
3. Subjects must have a randomization BG \<400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones).
4. Patients with expected hospital length-of-stay of 2 or more day

Exclusion Criteria

1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
2. Patients expected to require MRI procedures during hospitalization.
3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
6. Coronavirus Disease 2019 (COVID-19) infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No