Lipska, Kasia J.

Importance Continuous glucose monitoring (CGM), initially recommended primarily for people with type 1 diabetes, has rapidly expanded to patients with type 2 diabetes and, more recently, even to individuals without diabetes. This broadening use underscores the importance of critically examining the evidence supporting CGM across populations, clarifying where benefits are established, where they are modest, and where they remain uncertain. Observations We reviewed systematic reviews and meta-analyses of randomized trials and clinical guidelines evaluating CGM use beyond type 1 diabetes, with particular attention to glycemic outcomes, hypoglycemia, patient-reported outcomes, and potential unintended consequences in nonpregnant adults. In adults with type 2 diabetes, evidence from randomized trials consistently demonstrated that CGM use was associated, on average, with a modest yet consistent reduction in hemoglobin A 1c of approximately 0.3% compared with finger-stick monitoring or usual care; some patients benefited considerably more. Only limited and indirect evidence supported the adoption of CGM in people with type 2 diabetes not receiving glucose-lowering therapy or in those with prediabetes or obesity. Conclusions and Relevance CGM should be deployed in response to a specific patient problem rather than as a default intervention. Deliberate, equitable deployment of CGM that is aligned with patient goals, clinical context, and system capacity will be necessary to ensure that those most likely to benefit are not left behind, while avoiding overuse in populations for whom benefit remains unproven.

Abstract Background The self-management of type 2 diabetes (T2D) typically requires enacting various lifestyle changes, which can challenge people living with T2D. Clinical encounters between people with T2D and their clinicians, however, are often focused on metabolic management, leaving less time available for other self-management topics. The QBSAFE cards help patients articulate aspects of their experience with diabetes and prioritize issues for discussion. Methods This report details secondary outcomes of a randomized controlled trial; primary outcomes are reported elsewhere. All data was collected at Fair Haven Community Health Care, a federally qualified primary care clinic. 11 clinicians were randomly assigned to provide either usual care or usual care with QBSAFE cards to 155 of their patients with type 2 diabetes and hemoglobin A1c >8%. All patient encounters were video recorded for analysis. Patients and clinicians were not blinded to arm allocation but were kept unaware of the specific aims of the trial. Encounter video reviewers were blinded to arm allocation, but not to specific aims of the trial. The outcomes of interest for this report were the extent to which the QBSAFE cards were used as intended, their effect on the topics of discussion, and whether they enabled clinicians to notice and respond to each patient’s situation; comparisons between arms were conducted by a linear mixed model with fixed effect of arm and cluster effect of clinician, analyzed in both intent-to-treat and per-protocol populations. Findings 12 patients were excluded post-randomization (A1c <8%). Of 143 eligible patients, 137 encounters (65 in the usual care arm, 72 in QBSAFE) yielded evaluable videos. QBSAFE was used as intended in 61 (85%) QBSAFE arm encounters. Conversations about burden of treatment related to non-pharmacological interventions (17 vs 33, p = 0·04) and taking medications (11 vs 33, p = 0·0008) and about the patient’s challenging environment (2 vs 10, p = 0·04) were more prevalent in the QBSAFE group. There was no difference in the rate of conversations about metabolic management or of new care plans as a result of conversations between groups. Interpretation While there was a difference in the types of conversations observed between the two study arms, this difference was small and only apparent in a few domains. Future work could aim to modify the QBSAFE cards to more effectively stimulate patient-centered discussions and to further prepare clinicians to respond to a variety of issues raised during the clinical visit. Funding This work was supported by funding from the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK129616).

ABSTRACT Background Effective interventions are needed to support co-creation of diabetes care plans that fit patients’ lives. We evaluated the QBSafe agenda-setting kit (14 conversation cards) for its impact on care fit and glycemic control when added to usual primary care. Methods This single-center, clinician-level cluster-randomized, open-label trial was conducted at a federally qualified health center in New Haven, Connecticut ( ClinicalTrials.gov NCT05553912 ). Clinicians and their patients with type 2 diabetes and HbA1c >8% were randomized 1:1 to usual care with or without QBSafe cards. In the intervention arm, patients selected up to 3 cards highlighting concerns about life with diabetes prior to their visit. Primary outcomes were change at 6 months in care fit (Illness Intrusiveness Ratings Scale, IIRS) and HbA1c, analyzed by intention to treat. Secondary outcomes were treatment burden (Treatment Burden Questionnaire, TBQ) and diabetes distress (Diabetes Distress Scale, DDS), and satisfaction with visits. Results Between February 2023 and July 2024, 143 participants (mean age 56 years; 61% female; 73% Hispanic; mean HbA1c 10%) were enrolled: 74 received usual care with QBSafe, 69 usual care alone. At 6 months, there were no significant between-arm differences in changes in IIRS (−3.9 [95% CI -10.4, 2.6]), HbA1c (−0.2% [95% CI -0.9, 0.5]), TBQ (1.0 [95% CI -16.6, 18.6]), or DDS (−0.1 [95% CI -0.4, 0.2]). Clinicians reported greater satisfaction when using QBSafe. Patient satisfaction was high and did not differ across arms. Conclusions QBSafe cards improved clinician satisfaction but did not improve care fit or glycemic control. Future tools should focus on helping clinicians respond effectively to patient-identified challenges.

This article reports on a study to assess the feasibility of research procedures and acceptability of QBSAFE, a set of conversation cards focused on quality of life, treatment burden, safety, and avoidance of future events in people with type 2 diabetes. The study enrolled 84 patients and 7 clinicians. Of the 58 patients who completed questionnaires, 64% agreed that the QBSAFE agenda-setting kit (ASK) helped them discuss their situation, 78% agreed that others could benefit from it, and 38% said they would use it again. Most clinicians felt confident responding to issues (in 89% of encounters) and said they would use the kit again (78%) and recommend it to colleagues (82%). The QBSAFE ASK can be feasibly implemented and holds promise in facilitating discussion and collaborative problem-solving.

Abstract Purpose: Diabetes care has largely focused on reducing the risk of complications by achieving hemoglobin A1c (HbA1c) targets; yet, whole-person care may be more effective and desirable. We sought to determine the nature of discussions about quality of life, burden of treatment, hypoglycemia, sexual function, and social support during diabetes-focused clinical encounters.Methods: We analyzed 41 previously recorded clinical encounters with patients with type 2 diabetes from the control arms of practice-based trials of shared decision making. Two coders evaluated videos for discussions about aspects of life with diabetes: quality of life, burden of treatment, hypoglycemia, sexual function, and social supports. When an aspect was raised, coders evaluated the nature of the conversation, clinician responses, and time spent on discussing the aspect. Results: Median length of the encounter was 15 minutes, 6 seconds (IQR: 11:16 – 20:23 minutes). Thirty five of 41 encounters (85.4%), included some discussion of quality of life (58.5%), burden of treatment (51.2%), social support (2.4%), or hypoglycemia (9.8%). Sexual function was not discussed. On average, 4.5% (1.4%-5.5%) of the encounter time involved conversations about HbA1c whereas 15.0% (0%-25%) of the encounter was spent on some aspect of quality of life, burden of treatment, social support, or hypoglycemia. If a topic related to quality of life was raised, clinicians most often responded by acknowledging patient’s concern without providing a solution (45.8%). Conclusions: A significant part of the patient-clinician encounter involves discussion of quality of life and burden of treatment, but clinicians rarely address these issues by providing solutions.

Introduction Current diabetes quality measures are agnostic to patient clinical complexity and type of treatment required to achieve it. Our objective was to introduce a patient-centered indicator of appropriate diabetes therapy indicator (ADTI), designed for patients with type 2 diabetes, which is based on hemoglobin A1c (HbA1c) but is also contextualized by patient complexity and treatment intensity. Research design and methods A draft indicator was iteratively refined by a multidisciplinary Delphi panel using existing quality measures, guidelines, and published literature. ADTI performance was then assessed using OptumLabs Data Warehouse data for 2015. Included adults (n=206 279) with type 2 diabetes were categorized as clinically complex based on comorbidities, then categorized as treated appropriately, overtreated, or undertreated based on a matrix of clinical complexity, HbA1c level, and medications used. Associations between ADTI and emergency department/hospital visits for hypoglycemia and hyperglycemia were assessed by calculating event rates for each treatment intensity subset. Results Overall, 7.4% of patients with type 2 diabetes were overtreated and 21.1% were undertreated. Patients with high complexity were more likely to be overtreated (OR 5.60, 95% CI 5.37 to 5.83) and less likely to be undertreated (OR 0.65, 95% CI 0.62 to 0.68) than patients with low complexity. Overtreated patients had higher rates of hypoglycemia than appropriately treated patients (22.0 vs 6.2 per 1000 people/year), whereas undertreated patients had higher rates of hyperglycemia (8.4 vs 1.9 per 1000 people/year). Conclusions The ADTI may facilitate timely, patient-centered treatment intensification/deintensification with the goal of achieving safer evidence-based care.