N/A Completed N=84 Randomized Single-blind Treatment

Study to Understand Gaining Access to Blood Glucose Records

Diabetes

Source: ClinicalTrials.gov NCT02956642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcomePrimary: Mean HbA1c Levels — 8.0; 7.3; 7.9; 7.6 percentage of glycated hemoglobin

Summary

This study is a two-arm randomized controlled trial in which participants will receive either the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The study hypothesizes the use of the Livongo Health system results in a greater improvement in A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth Bluetooth-enabled glucose meter.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean HbA1c Levels	8.0; 7.3; 7.9; 7.6; 7.9; 7.5	—
PRIMARY Change in HbA1c	0.31; 0.38	—
SECONDARY Mean Fasting LDL	81; 94.5; 73.9; 98.2; 87.9; 92.7	—
SECONDARY Change in Fasting LDL	-0.3; -25.25	—

Eligibility Criteria

Inclusion Criteria

People with type 2 diabetes mellitus on any type of medication
Adults, age 18 years or older
iOS Smartphone with access to data and/or Wi-Fi
Willing to answer survey questions throughout the study
Willing to visit a lab for 3 blood draws at no cost to participants

Exclusion Criteria

Using continuous glucose monitoring during the study period
Using an insulin pump during the study period
Unable or unwilling to switch blood glucose meters to the study meter
Hospitalization for Diabetic ketoacidosis (DKA) or hypoglycemia in the past 1 month prior to enrollment
Pregnant patients, or intention to become pregnant during the study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02956642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.