Type 1 Diabetes MellitusTANGONCT03078491
Technological Advances in Glucose Management in Older Adults
A study testing eCGM (enhanced CGM) in people with Type 1 Diabetes Mellitus and Older Adults, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Older Adults, Hypoglycemia
- What is being tested?
- eCGM (enhanced CGM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with age ≥ 65 years
- Community-living
- Clinical diagnosis of T1D
- On multiple insulin injections (≥3 injection/s day) or insulin pump.
Who cannot join
- Use of real-time CGM in past 2 years
- A1c > 10% (since individuals with very poor glycemic control usually have barriers to optimal self-care that preclude effective use of technology)
- Use of insulin pump that cannot be uploaded for CDS
- Unable or unwilling to perform task needed for study participation during the run-in period
- Severe vision or hearing impairment that could interfere with study tasks
- Need to use acetaminophen on regular basis (since can interfere with CGM accuracy)
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- Living in an institutional setting (e.g. group homes, nursing homes)
- Terminal diseases with life expectancy < 1 year (e.g. malignancy)
- Severe comorbidities that prevent completing outcome measurements (e.g. severe dementia, severe vision impairment, severe functional disabilities, inability to perform basic activities of daily living)
- Alcohol or other drug abuse
- Conditions that impact wear of CGM (e.g. CHF with edema, skin conditions); and
- End stage renal insufficiency (eGFR<30), or on dialysis (since impact of fluid shift on sensor lag not clearly understood).
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.
Read the detailed description
Hypoglycemia is a major and often devastating complication of T1D in the elderly. CGM has been shown to reduce the risk for hypoglycemia in adults with T1D including some more functional patients over 65 years old. However, the Medicare population is heterogeneous and may have age-related clinical and functional impairments that can impact self-care. These patients will require additional targeted guidance and support to fully realize the potential benefits of CGM. To address these age-specific barriers which could limit the effective use of CGM, in our planned RCT (Specific Aim 1) the use of CGM will be coupled with the DMP (Diabetes Management Platform), a tablet-based technology platform ( termed enhanced CGM (eCGM)). The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The use of the DMP is expected to help the less technologically proficient Medicare patients to derive benefit from CGM. Specific Aim 2 will involve extensive mixed methods research (including semi-structured interviews of patients and caregivers) directed at making an in-depth assessment of barriers to the use of diabetes technology in older adults. This investigation will provide the evidence-base for future improvements in both the technology and clinical approach to the training of older adults and their caregivers. Specific Aim 3 will involve a cost-effectiveness analysis of the technology system (CGM with DMP = enhanced CGM [eCGM]) used in the trial as well as quality of life measures, providing a foundation for decision-making on coverage.
- Conditions
- Type 1 Diabetes Mellitus, Older Adults, Hypoglycemia
- Being tested
- eCGM (enhanced CGM)
- Keywords
- type 1 diabetes, geriatrics, older adults, technology, CGM, clinical decision support, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCGM (enhanced CGM)Other
Glucose (CGM and Bluetooth BG meter), insulin (pump or Bluetooth insulin pen) and activity data will be automatically uploaded via the subjects' tablet computers, and analyzed by the CDS. The CDS will, if indicated generate adjustable insulin dosing recommendations that will compensate for different insulin requirements following high vs low activity days. The recommendations of the CDS will be used by the clinical team in their therapeutic decision-making about insulin dosing adjustments at the scheduled study follow up visits and the remote visits between these in-person visits. In addition, study staff will provide recommendations regarding hypoglycemic warning symptoms, causes, and appropriateness of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will use eCGM (CGM with Diabetes Management Platform(DMP)) and an activity meter. The DMP will be pre-loaded with geriatric-specific education material, weblink to online education and surveys. The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The DMP can also be configured to route the insulin regimen change approved by the study physician to the designated care providers of the patient. Blue-tooth unabled insulin pens will also provide additional data to verify if the patient is taking recommended insulin doses. Receives: Other: eCGM (enhanced CGM) |
| Attention Control | No intervention | The attention control group will receive an android tablet pre-loaded with activity monitor devices, education material, and weblink to online education and surveys. However, the data will not be analyzed by CDS. An independent physician and a study staff member- only caring for the control group subjects will review the insulin and glucose data at in-person and remote study visits and make appropriate dosing adjustments based on self monitoring glucose levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in duration of hypoglycemia
Minutes per day CGM < 70 mg/dL assessed over 2 weeks CGM use (blinded in the control arm; unblinded in the treatment arm)
Measured: change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups
Secondary outcomes (6)
Fasting and bedtime CGM glucose values per day
Difference from fasting and bedtime CGM glucose values per day
Measured: change in glucose values(mg/dl) from baseline to 6 months between intervention and control groups
Severe biochemical hypoglycemia
Incidence of severe biochemical hypoglycemia (defined as CGM below 54mg/dL for > than 20 minutes) assessed over 2 weeks CGM use (blinded in the control arm; unblinded in the treatment arm)
Measured: change in severe biochemical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
Severe clinical hypoglycemia
Incidence of clinically severe hypoglycemia (requiring third party assistance or loss of consciousness) measured by clinical history,
Measured: change in severe clinical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
Hemoglobin A1C
A1C measured by laboratory test
Measured: Change in A1C (%) from baseline to 6 months between intervention and control groups
Cost-effectiveness and cost-utility
cost-effectiveness and cost-utility of using eCGM versus usual care with self-monitoring glucose monitoring by calculating the incremental cost-effectiveness ratios
Measured: 6 months
Barriers and facilitators of CGM use
Mixed-method approach using semi-structured interviews to assess barriers and facilitators in those participants who fail the pretrial run-in and those who derive benefits from eCGM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start30 Mar 2017
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Children's Hospital, RTI International
- Responsible party
- Sponsor
- Investigators
- Medha N Munshi, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078491
- Sponsor's protocol ID
- CHS #2016-29
- Acronym
- TANGO
- Status last verified
- May 2026
- First submitted
- 21 Feb 2017
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munshi M, Slyne C, Adam A, Davis D, Michals A, Atakov-Castillo A, Weinger K, Toschi E. Impact of Diabetes Duration on Functional and Clinical Status in Older Adults With Type 1 Diabetes. Diabetes Care. 2022 Mar 1;45(3):754-757. doi: 10.2337/dc21-2000.
PubMed 35076712Munshi M, Slyne C, Davis D, Michals A, Sifre K, Dewar R, Atakov-Castillo A, Toschi E. Use of Technology in Older Adults with Type 1 Diabetes: Clinical Characteristics and Glycemic Metrics. Diabetes Technol Ther. 2022 Jan;24(1):1-9. doi: 10.1089/dia.2021.0246.
PubMed 34524033Toschi E, Slyne C, Sifre K, O'Donnell R, Greenberg J, Atakov-Castillo A, Carl S, Munshi M. The Relationship Between CGM-Derived Metrics, A1C, and Risk of Hypoglycemia in Older Adults With Type 1 Diabetes. Diabetes Care. 2020 Oct;43(10):2349-2354. doi: 10.2337/dc20-0016. Epub 2020 May 27.
PubMed 32461211Toschi E, Munshi MN. Benefits and Challenges of Diabetes Technology Use in Older Adults. Endocrinol Metab Clin North Am. 2020 Mar;49(1):57-67. doi: 10.1016/j.ecl.2019.10.001. Epub 2019 Nov 18.
PubMed 31980121
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological Advances in Glucose Management in Older Adults
- ClinicalTrials.gov ID
- NCT03078491
- Acronym / sponsor ID
- TANGO / CHS #2016-29
- Conditions
- Type 1 Diabetes Mellitus, Older Adults, Hypoglycemia
- Keywords
- type 1 diabetes, geriatrics, older adults, technology, CGM, clinical decision support, hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Children's Hospital, RTI International
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 13 Mar 2017 (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.
This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.
Detailed description
Hypoglycemia is a major and often devastating complication of T1D in the elderly. CGM has been shown to reduce the risk for hypoglycemia in adults with T1D including some more functional patients over 65 years old. However, the Medicare population is heterogeneous and may have age-related clinical and functional impairments that can impact self-care. These patients will require additional targeted guidance and support to fully realize the potential benefits of CGM. To address these age-specific barriers which could limit the effective use of CGM, in our planned RCT (Specific Aim 1) the use of CGM will be coupled with the DMP (Diabetes Management Platform), a tablet-based technology platform ( termed enhanced CGM (eCGM)). The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The use of the DMP is expected to help the less technologically proficient Medicare patients to derive benefit from CGM. Specific Aim 2 will involve extensive mixed methods research (including semi-structured interviews of patients and caregivers) directed at making an in-depth assessment of barriers to the use of diabetes technology in older adults. This investigation will provide the evidence-base for future improvements in both the technology and clinical approach to the training of older adults and their caregivers. Specific Aim 3 will involve a cost-effectiveness analysis of the technology system (CGM with DMP = enhanced CGM [eCGM]) used in the trial as well as quality of life measures, providing a foundation for decision-making on coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: eCGM (enhanced CGM)The intervention group will use eCGM (CGM with Diabetes Management Platform(DMP)) and an activity meter. The DMP will be pre-loaded with geriatric-specific education material, weblink to online education and surveys. The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The DMP can also be configured to route the insulin regimen change approved by the study physician to the designated care providers of the patient. Blue-tooth unabled insulin pens will also provide additional data to verify if the patient is taking recommended insulin doses. |
| Attention Control | No intervention | –The attention control group will receive an android tablet pre-loaded with activity monitor devices, education material, and weblink to online education and surveys. However, the data will not be analyzed by CDS. An independent physician and a study staff member- only caring for the control group subjects will review the insulin and glucose data at in-person and remote study visits and make appropriate dosing adjustments based on self monitoring glucose levels |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with age ≥ 65 years
- Community-living
- Clinical diagnosis of T1D
- On multiple insulin injections (≥3 injection/s day) or insulin pump.
Key exclusion criteria (12 listed)
- Use of real-time CGM in past 2 years
- A1c > 10% (since individuals with very poor glycemic control usually have barriers to optimal self-care that preclude effective use of technology)
- Use of insulin pump that cannot be uploaded for CDS
- Unable or unwilling to perform task needed for study participation during the run-in period
- Severe vision or hearing impairment that could interfere with study tasks
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 |
|---|---|---|
| eCGM (enhanced CGM)Glucose (CGM and Bluetooth BG meter), insulin (pump or Bluetooth insulin pen) and activity data will be automatically uploaded via the subjects' tablet computers, and analyzed by the CDS. The CDS will, if indicated generate adjustable insulin dosing recommendations that will compensate for different insulin requirements following high vs low activity days. The recommendations of the CDS will be used by the clinical team in their therapeutic decision-making about insulin dosing adjustments at the scheduled study follow up visits and the remote visits between these in-person visits. In addition, study staff will provide recommendations regarding hypoglycemic warning symptoms, causes, and appropriateness of treatment. | Other | Intervention |
Primary outcome
Change in duration of hypoglycemia
Time frame: change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups
Minutes per day CGM < 70 mg/dL assessed over 2 weeks CGM use (blinded in the control arm; unblinded in the treatment arm)
6 secondary outcomes
Fasting and bedtime CGM glucose values per day
Time frame: change in glucose values(mg/dl) from baseline to 6 months between intervention and control groups
Severe biochemical hypoglycemia
Time frame: change in severe biochemical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
Severe clinical hypoglycemia
Time frame: change in severe clinical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
Hemoglobin A1C
Time frame: Change in A1C (%) from baseline to 6 months between intervention and control groups
Cost-effectiveness and cost-utility
Time frame: 6 months
Barriers and facilitators of CGM use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 35076712Munshi M, Slyne C, Adam A, Davis D, Michals A, Atakov-Castillo A, Weinger K, Toschi E. Impact of Diabetes Duration on Functional and Clinical Status in Older Adults With Type 1 Diabetes. Diabetes Care. 2022 Mar 1;45(3):754-757. doi: 10.2337/dc21-2000.
- Derived from this study: PubMed 34524033Munshi M, Slyne C, Davis D, Michals A, Sifre K, Dewar R, Atakov-Castillo A, Toschi E. Use of Technology in Older Adults with Type 1 Diabetes: Clinical Characteristics and Glycemic Metrics. Diabetes Technol Ther. 2022 Jan;24(1):1-9. doi: 10.1089/dia.2021.0246.
- Derived from this study: PubMed 32461211Toschi E, Slyne C, Sifre K, O'Donnell R, Greenberg J, Atakov-Castillo A, Carl S, Munshi M. The Relationship Between CGM-Derived Metrics, A1C, and Risk of Hypoglycemia in Older Adults With Type 1 Diabetes. Diabetes Care. 2020 Oct;43(10):2349-2354. doi: 10.2337/dc20-0016. Epub 2020 May 27.
- Derived from this study: PubMed 31980121Toschi E, Munshi MN. Benefits and Challenges of Diabetes Technology Use in Older Adults. Endocrinol Metab Clin North Am. 2020 Mar;49(1):57-67. doi: 10.1016/j.ecl.2019.10.001. Epub 2019 Nov 18.
- 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. This study is not recruiting at the moment.
Medha N Munshi, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCGM (enhanced CGM) in people with Type 1 Diabetes Mellitus and Older Adults, run by Joslin Diabetes Center at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in duration of hypoglycemia (time frame: change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078491, which also lists 4 linked publications.
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 12 May 2026.