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Completed

NCT Number: NCT04473430

Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Clinic, Atlanta, Georgia, United States

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About this study

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis. The study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult subjects with type 2 diabetes
  • receiving hemodialysis (for at least 90 days)
  • treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, detemir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (DPPIV or GLP1)
  • willingness to wear the CGM
  • currently performing self-monitored blood glucose (at least 2 times daily).

Exclusion criteria

  • use of sulfonylureas or thiazolidinediones alone or in combination with insulin
  • use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed)
  • prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days)
  • current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed)
  • subjects who are sensitive or allergic to adhesive
  • extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
  • any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples
  • situations that will limit the subject's ability to comply with the protocol (per investigator discretion)
  • active malignancy
  • unable to give informed consent
  • at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period
  • significant hypoglycemia (< 40 mg/dL)
  • severe hyperglycemia (BG> 400 mg/dL)
  • extensive skin abnormalities at insertion sites
  • pregnancy or breastfeeding
  • severe anemia (Hemoglobin < 5 mg/dl)
  • polycythemia (Hemoglobin >17 mg/dl)
  • subjects taking acetaminophen (more than 1 gr every six hours)
  • hydroxyurea (may cause interference with the sensor membrane).

Treatment and study plan

Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)

Device

Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance.

Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).

Diagnostic Test: Real-time CGM will be used to collect outcomes variables

POC Glucose Testing

Device

POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.

Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing).

Primary outcomes

  1. Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)

    Time frame: 8 weeks (after completion of both phases)

    Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

    Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).

Secondary outcomes

  1. % Time in Target Range (70-180 mg/dl)

    Time frame: 8 weeks (after completion of both phases)

    % time in target range (70-180 mg/dl) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

    Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).

  2. Mean % Time in Hypoglycemia (< 54 mg/dL)

    Time frame: 8 weeks (after completion of both phases)

    % time in hypoglycemia (<54 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

  3. % Time in Hyperglycemia (>180 mg/dL)

    Time frame: 8 weeks (after completion of both phases)

    % time in hyperglycemia (>180 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

  4. % Time in Hyperglycemia (>250 mg/dl)

    Time frame: 8 weeks (after completion of both phases)

    % time in hyperglycemia (>250 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

  5. Glycemic Variability [% Coefficient of Variation (%CV)

    Time frame: 8 weeks (after completion of both phases)

    % coefficient of variation will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

  6. Mean Amplitude of Glucose Excursions (MAGE)

    Time frame: 8 weeks (after completion of both phases)

    Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.

  7. HbA1C at 3 Months Follow up

    Time frame: Baseline, 3 months post-intervention

    HbA1C at 3 months follow up from baseline. Data will be exported from the electronic medical records.

  8. Number of Hospitalization or Emergency Room Visits for Hypoglycemia

    Time frame: Baseline, 3 months post-intervention

    Rate of hospitalization or emergency room (ER) visits for hypoglycemia will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.

  9. Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)

    Time frame: Baseline, 3 months post-intervention

    Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2020
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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