Safer Aging With Diabetes Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorKaiser Permanente
About this trial
Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 75 years and older
Diagnosis of Type 2 Diabetes
Current treatment with insulin
Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)
Disqualifiers
On renal dialysis
Dementia
Pacemaker or Automatic Implantable Cardioverter Defibrillator
Using insulin pump
Trial design
Design model
Parallel
Treatments tested in this trial
SAGE Group Sessions
BehavioralParticipants enroll in 3 educational group sessions and receive CGMs
Usual Care
Other interventionParticipants continue to receive usual care (Control Arm)
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Group Education SessionsExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hypoglycemia aggregate outcome
This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others) and/or hypoglycemia-related utilization (emergency department, hospital or outpatient new events) 6- and 12-months after enrollment
Time frame
6 and 12 months after study start dateSecondary outcomes
1
Self-reported hypoglycemia
This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others)
Time frame
6 and 12 months after study start date2
Hypoglycemia-related utilization
This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events)
Time frame
6 and 12 months after study start date3
Diabetes Distress
This outcome will compare responses to the 2-item, validated Diabetes Distress survey
Time frame
6 and 12 months after study start date4
Hypoglycemia Confidence
This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey
Time frame
6 and 12 months after study start dateOther outcomes
1
Technology Proficiency
This outcome will compare responses to a 3-item subset of the validated Technology Proficiency survey
Time frame
6 and 12 months after study start date2
Confidence in Adjusting Insulin
This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey
Time frame
6 and 12 months after study start date3
Insulin Adjustment
This outcome will assess patient self-report of changes to insulin regimen in preceding 6 months
Time frame
6 and 12 months after study start date4
Caregiver Action
This outcome will assess patient self-report of caregiver taking action to address low blood sugar in preceding 6 months
Time frame
6 and 12 months after study start dateSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov