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Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 3 months, 12 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for approximately 12 weeks after discharge, with an early follow-up encounter and a final assessment at 12 weeks."
  • "The primary outcome is HbA1c at 12 weeks, a blood test that reflects average blood glucose levels over approximately three months."
  • "A Veterans Affairs system analysis of 15,706 patients with type 2 diabetes on insulin showed that CGM initiation was associated with reduced risk of hyperglycemia-related hospitalizations (HR 0.87) and all-cause hospitalization (HR 0.89) over 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether starting a continuous glucose monitor (CGM), a device that tracks blood sugar, before leaving the hospital works better than finger-stick checks. It is for adults with type 2 diabetes and an A1c of 9% or higher who will return home from the hospital. The study will track blood sugar control for about 12 weeks.

The TRANSITION-CGM trial will evaluate whether starting continuous glucose monitoring (CGM) before hospital discharge improves blood glucose control in adults with type 2 diabetes compared with usual care using finger-stick blood glucose checks. The study focuses on the transition from hospital to home, when patients may face changes in diabetes medications and challenges managing their blood glucose levels. This single-center, randomized controlled trial will enroll approximately 218 adults with type 2 diabetes, a hemoglobin A1c (HbA1c) 9% and above, and treatment with insulin and/or oral diabetes medications. Participants will be recruited during hospitalization and must be expected to return home after discharge. People already using a CGM will not be eligible. Participants will be randomly assigned in equal numbers to one of two groups. The CGM group will start using a continuous glucose monitor before discharge and receive device training and written instructions. The usual-care group will continue finger-stick blood glucose monitoring and receive standard discharge education. Both groups will receive assistance with outpatient diabetes follow-up. Diabetes medications will be managed by treating clinicians according to usual clinical practice. Participants will be followed for approximately 12 weeks after discharge, with an early follow-up encounter and a final assessment at 12 weeks. The primary outcome is HbA1c at 12 weeks, a blood test that reflects average blood glucose levels over approximately three months. Secondary outcomes include diabetes-related hospitalizations and episodes of low blood sugar. Additional exploratory measures include CGM use, follow-up attendance, patient-reported experiences, and time spent within the target glucose range when CGM data are available. The study will determine whether initiating CGM during hospitalization can improve glycemic control after discharge and provide preliminary evidence about its effects on diabetes-related hospitalizations and hypoglycemia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have type 2 diabetes, either newly diagnosed or known before the hospital stay.
  • Have an A1c of 9% or higher. This blood test shows average blood sugar over about 3 months.
  • Use insulin, diabetes pills, or both during the current hospital stay.
  • Expect to go home from the hospital within 48–72 hours.
  • Can agree to join the study and attend a follow-up visit at 12 weeks.

Who can't join

  • Already use a CGM, or cannot have one placed because of a problem such as a severe skin allergy.
  • Have a mental health condition that prevents agreeing to join or following study steps.
  • Have trouble thinking or dementia that makes device use or self-care difficult.
  • Do not have stable housing, or are in or will go to a skilled nursing facility.
  • Are pregnant or have end-stage kidney disease, the most advanced stage of kidney disease.
  • Take steroids at a daily dose equal to 10 mg or more of prednisone.
  • Have an A1c below 9%.
  • Have a hemoglobin disorder—a problem with the protein in red blood cells—that makes A1c results unreliable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Established or new diagnosis of type 2 diabetes mellitus (T2DM) * HbA1C \>/= 9% * On insulin therapy and/or oral hypoglycemic agents at time of index hospitalization * Anticipated discharge to home within 48-72 hours * Ability to provide informed consent and attend 12-week follow-up Exclusion Criteria: * Active psychiatric illness that interferes with consent or study adherence * Cognitive disturbance/dementia impairing device use or self-care * Housing instability * Skilled nursing facility (SNF) admission or planned discharge to SNF * Contraindication to CGM placement (e.g., severe skin allergy) * Pre-existing established CGM use * Pregnancy * ESRD * Steroid use (Prednisone equivalent 10 mg/day or more) * HgbA1C \< 9% * Hemoglobinopathy (where HgbA1C is not reliable)

Study sites (1)

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