Diabetes Mellitus, Type 2
Conditions
Brief summary
The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care support intervention facilitated by cellular-enabled glucose meters in adults with persistent poor control of type 2 diabetes.
Detailed description
A 2-group randomized crossover trial comparing usual care to a diabetes care support intervention among patients with repeated HbA1c recordings greater than 8.0 percent during the previous 12 months. The intervention included 6 months of enrollment in Livongo for Diabetes, a Certified Diabetes Educator (CDE) based remote diabetes monitoring program facilitated by cellular-enabled glucose meters, with additional remote monitoring by their usual care team. HbA1c levels were recorded at enrollment and 3, 6, 9, and 12 months post enrollment. Questionnaire data were collected at baseline, 6 months, and 12 months post enrollment. Primary outcomes evaluated were change in HbA1c and treatment satisfaction at the 6 month endpoint with secondary outcomes of change in HbA1c and treatment satisfaction at the 12 month endpoint.
Interventions
OTHERLivongo for Diabetes program
See description in arm/group description.
Sponsors
Livongo Health
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment
Exclusion criteria
* excluded if they were cognitively impaired, pregnant, or prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | During 6-month enrollment in Intervention | The primary physiological outcome of this study was change in HbA1c during enrollment in the intervention compared to change while receiving usual care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Treatment Satisfaction | During 6-month enrollment in intervention | The secondary outcome of this study was change in treatment satisfaction during enrollment in the intervention compared to change while receiving usual care. Treatment Satisfaction Change was measured using the Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scale. |
Outcome results
None listed