N/A
N=84
Study to Understand Gaining Access to Blood Glucose Records
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02956642 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Mean HbA1c Levels — 8.0; 7.3; 7.9; 7.6 percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Livongo Health System (Device); iHealth Glucose Meter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2021
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 | — |
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.
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
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.