Trial Outcomes & Findings for 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) (NCT NCT04473430)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

8 weeks (after completion of both phases)

Results posted on

2025-02-10

Participant Flow

Of the 66 individuals who signed the informed consent form (ICF), 53 took part in the study. The remaining 13 individuals did not proceed to the study due to screening failure. Therefore, the following tables include data only from the 53 participants who began the study.

Participant milestones

Participant milestones
Measure	Real-time Dexcom CGM During CGM Intervention, Then Professional Dexcom CGM During POC Intervention Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks. Dexcom real-time G6 CGM System: 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. It uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. It 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	Professional Dexcom CGM During POC Intervention, Then Real-time Dexcom CGM During CGM Intervention Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks (Control-Intervention Group). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
Phase I (First Intervention - 4 Weeks) STARTED	25	28
Phase I (First Intervention - 4 Weeks) COMPLETED	21	27
Phase I (First Intervention - 4 Weeks) NOT COMPLETED	4	1
Phase II (Second Intervention - 4 Weeks) STARTED	21	27
Phase II (Second Intervention - 4 Weeks) Excluded From Analysis	1	0
Phase II (Second Intervention - 4 Weeks) COMPLETED	17	23
Phase II (Second Intervention - 4 Weeks) NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)