Diabetes Mellitus, Type 2SAGENCT06296485
Safer Aging With Diabetes Monitoring
A study testing SAGE Group Sessions in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Kaiser Permanente at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemia
- What is being tested?
- SAGE Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
- Able to communicate in English
- Able to access email and the Internet
Who cannot join
- On renal dialysis
- Dementia
- Pacemaker or Automatic Implantable Cardioverter Defibrillator
- Using insulin pump
- Severe Mental Illness
- Severe Visual Impairment
- In Hospice
- Current or recent CGM use
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 1 recruiting
- Completed
Kaiser Permanente Fremont
Fremont, California, 94538
- Recruiting
Kaiser Permanente Sacramento
Sacramento, California, 95814
Emma Fernandez, emma.m.fernandez@kp.org
- Completed
Kaiser Permanente San Jose
San Jose, California, 94538
- Completed
Kaiser Permanente San Leandro
San Leandro, California, 94577
- Completed
Kaiser Permanente Santa Clara
Santa Clara, California, 95050
- Completed
Kaiser Permanente - Union City
Union City, California, 94587
About this study
Official title: Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
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.
Read the detailed description
The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Being tested
- SAGE Group Sessions, Usual Care
- Keywords
- Hypoglycemia, Diabetes Education, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE Group SessionsBehavioural
Participants enroll in 3 educational group sessions and receive CGMs
Usual CareOther
Participants continue to receive usual care (Control Arm)
| Study group | Role | What they receive |
|---|---|---|
| Group Education Sessions | Experimental | Participants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors [CGMs] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 \& 3). Receives: Behavioral: SAGE Group Sessions |
| Usual Care | Active comparator | Participants allocated to the control arm will continue with usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 and 12 months after study start date
Secondary outcomes (5)
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)
Measured: 6 and 12 months after study start date
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)
Measured: 6 and 12 months after study start date
Diabetes Distress
This outcome will compare responses to the 2-item, validated Diabetes Distress survey
Measured: 6 and 12 months after study start date
Hypoglycemia Confidence
This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey
Measured: 6 and 12 months after study start date
Hypoglycemia Distress
This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey
Measured: 6 and 12 months after study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 May 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm pragmatic randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard W Grant, MD MPH, Principal investigator, Kaiser Permanente Northern California - Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296485
- Sponsor's protocol ID
- IRB-1996616
- Other IDs
- R01DK134446
- Acronym
- SAGE
- Status last verified
- Feb 2026
- First submitted
- 29 Feb 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06296485
- Acronym / sponsor ID
- SAGE / IRB-1996616
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Keywords
- Hypoglycemia, Diabetes Education, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm pragmatic randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group Education Sessions | Experimental | Behavioral: SAGE Group SessionsParticipants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors [CGMs] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 \& 3). |
| Usual Care | Active comparator | Other: Usual CareParticipants allocated to the control arm will continue with usual care. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
- Able to communicate in English
Key exclusion criteria (8 listed)
- On renal dialysis
- Dementia
- Pacemaker or Automatic Implantable Cardioverter Defibrillator
- Using insulin pump
- Severe Mental Illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE Group SessionsParticipants enroll in 3 educational group sessions and receive CGMs | Behavioural | Group Education Sessions |
| Usual CareParticipants continue to receive usual care (Control Arm) | Other | Usual Care |
Primary outcome
Hypoglycemia aggregate outcome
Time frame: 6 and 12 months after study start date
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
5 secondary outcomes
Self-reported hypoglycemia
Time frame: 6 and 12 months after study start date
Hypoglycemia-related utilization
Time frame: 6 and 12 months after study start date
Diabetes Distress
Time frame: 6 and 12 months after study start date
Hypoglycemia Confidence
Time frame: 6 and 12 months after study start date
Hypoglycemia Distress
Time frame: 6 and 12 months after study start date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard W Grant, MD MPH principal investigator
Kaiser Permanente Northern California - Division of Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAGE Group Sessions in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Kaiser Permanente at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Gonzalez (866-206-2969, Susana.C.Gonzalez@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia aggregate outcome (time frame: 6 and 12 months after study start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.