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Yeh HC, Lau BD, Golden SH, et al. Insulin Delivery and Glucose Monitoring Methods: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 57 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. (Future Research Needs Papers, No. 32.)
Insulin Delivery and Glucose Monitoring Methods: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 57 [Internet].
Show detailsResearch Needs
Type 1 Diabetes
Phase 1
During phase 1 of this study, population research gaps identified included children (age less than 13 years), adolescents (age 13 to 19 years), adults (age 20–64 years), and the elderly (age ≥ 65 years) with type 1 diabetes (see Table 2). Potential research needs for insulin delivery methods were CSII (i.e. insulin pump), reactive low glucose suspend pumps (i.e. pump that automatically suspends insulin delivery when glucose reaches low threshold), artificial pancreas (i.e. overnight closed loop, senses upper and lower glucose thresholds), and sensor-augmented insulin pumps (see Table 3). Potential blood glucose monitoring methods for future research identified were SMBG, retrospective continuous glucose monitoring, and real-time continuous glucose monitoring (see Table 4). Outcomes identified for future research were HbA1c, adherence, non-severe hypoglycemia, severe hypoglycemia, and hyperglycemia (see Table 5).
Table 2
Stakeholder identification and prioritization of populations of greatest importance for future research for insulin delivery and blood glucose monitoring methods among patients with type 1 diabetes.
Table 3
Stakeholder identification and prioritization of insulin delivery methods of greatest importance for future research among patients with type 1 diabetes.
Table 4
Stakeholder identification and prioritization of blood glucose monitoring methods of greatest importance for future research among patients with type 1 diabetes.
Table 5
Stakeholder identification and prioritization of clinical outcomes of greatest importance for future research of insulin delivery and glucose monitoring methods among patients with type 1 diabetes.
Phase 2
During phase 2, three expert stakeholders ranked adolescents as the highest priority among type 1 patients with diabetes for future research. (see Table 2). One stakeholder ranked children and one ranked adults as the highest priority for future research. Among children with type 1 diabetes, three Stakeholders ranked artificial pancreas as the highest research need for insulin delivery while one Stakeholder ranked reactive glucose suspend pump and one ranked sensor-augmented insulin pump as the highest priorities for this population. Among adolescents with type 1 diabetes, three Stakeholders also ranked artificial pancreas as the highest priority for future research while two prioritized sensor-augmented insulin pump. For adults with type 1 diabetes, two Stakeholders prioritized artificial pancreas and two prioritized sensor-augments insulin pump for future research. One Stakeholder prioritized reactive low glucose suspend pump as the highest priority for future research. Four stakeholders ranked reactive low glucose suspend pump as the highest priority for future research among the elderly with type 1 diabetes and one Stakeholder ranked artificial pancreas as the highest priority (see Table 3).
For glucose monitoring methods, all stakeholders prioritized rt-CGM for anyone with type 1 diabetes (see Table 4).
Three stakeholders ranked adherence as the highest priority among children with type 1 diabetes. For adolescents, two stakeholders rated adherence as highest priority while the other two ranked severe hypoglycemia as highest priority. Among adults, three stakeholders ranked severe hypoglycemia as high priority; and in elderly, all stakeholders rated severe hypoglycemia as a high priority (see Table 5).
Phase 3
Consensus was achieved during phase 2, negating the need to build consensus in phase 3.
Phase 4
When presented with the research questions developed from feedback in earlier rounds, Stakeholders prioritized glucose monitoring as a higher research need above insulin delivery methods.
Type 2 Diabetes
Phase 1
During phase 1 of this study adolescents (age 13 to 19 years), adults (age 20–64 years) and elderly (age greater than 64) with type 2 diabetes were identified as research gaps (see Table 6). Research gaps for insulin delivery methods were CSII (i.e. insulin pump), reactive low glucose suspend pumps (i.e. pump that automatically suspends insulin delivery when glucose reaches low threshold), artificial pancreas (i.e. overnight closed loop, senses upper and lower glucose thresholds), and sensor-augmented insulin pumps (see Table 7). Potential blood glucose monitoring methods for future research identified were SMBG, retrospective continuous glucose monitoring, and rt-CGM (see Table 8). Outcomes identified for future research were HbA1c, adherence, non-severe hypoglycemia, severe hypoglycemia, hyperglycemia, and weight (see Table 9).
Table 6
Results of each phase for the identification and prioritization of future research for insulin delivery and blood glucose monitoring methods among insulin-requiring patients with type 2 diabetes.
Table 7
Stakeholder identification and prioritization of insulin delivery methods of greatest importance for future research among insulin-requiring patients with type 2 diabetes.
Table 8
Stakeholder identification and prioritization of blood glucose monitoring methods of greatest importance for future research among insulin-requiring patients with type 2 diabetes.
Table 9
Stakeholder identification and prioritization of clinical outcomes of greatest importance for future research of insulin delivery and glucose monitoring methods among patients with type 2 diabetes by population.
Phase 2
During phase 2, three Stakeholders ranked adults as the highest priority among insulin-requiring patients with type 2 diabetes for future research. One stakeholder ranked adolescents and one ranked elderly as the highest priority for future research (see Table 6). Among the patients with insulin-requiring type 2 diabetes, three Stakeholders ranked sensor-augmented insulin pump as the highest research need for insulin delivery while one stakeholder ranked CSII and one prioritized artificial pancreas as the highest priorities for this future research (see Table 7). For glucose monitoring methods, three Stakeholders prioritized rt-CGM and two prioritized SMBG for patients with insulin-requiring type 2 diabetes (see Table 8).
Two Stakeholders prioritized HbA1c, one prioritized severe hypoglycemia and one ranked weight as the highest priority among adolescents with insulin-requiring type 2 diabetes. Three Stakeholders prioritized HbA1c, one prioritized adherence and one ranked hyperglycemia as the highest priority among adults with insulin-requiring type 2 diabetes. Three Stakeholders prioritized HbA1c, one prioritized severe hypoglycemia and one ranked hyperglycemia as the highest priority among the elderly with insulin-requiring type 2 diabetes (Table 9).
Phase 3
Consensus was also achieved for insulin-requiring type 2 diabetes during phase 2.
Phase 4
When presented with the research questions developed from feedback in earlier rounds, Stakeholders prioritized glucose monitoring as a higher research need above insulin delivery methods.
Research Questions
Based on stakeholder feedback from phase 2 regarding populations, intervention comparisons, and outcomes, the following four research questions developed for future research were prioritized by our stakeholders:
- For adolescents with type 1 diabetes, what is the comparative effectiveness of an artificial pancreas versus other methods of insulin delivery for the outcomes of adherence and severe hypoglycemia?
- For adolescents with type 1 diabetes, what is the comparative effectiveness of rt-CGM versus other methods of glucose monitoring for the outcomes of adherence and severe hypoglycemia?
- For adults with insulin-requiring type 2 diabetes, what is the comparative effectiveness of a sensor-augmented insulin pump versus other methods of insulin delivery for the outcome HbA1c ?
- For adults with insulin-requiring type 2 diabetes, what is the comparative effectiveness of rt-CGM versus other methods of glucose monitoring for the outcome HbA1c ?
This report reinforces the needs for future research that we outlined in the original evidence report,9 and points to specific types of studies that should have a high priority. In the original report, we identified a need for well-conducted RCTs of intensive insulin therapy delivered via CSII versus MDI in young children with type 1 diabetes and elderly patients with both type 1 and type 2 diabetes. Based on the input from our stakeholders, higher priority should be given to RCTs of intensive insulin therapy options, including the artificial pancreas, in adolescents with type 1 diabetes. Such studies should be accompanied by efforts to assess the comparative effectiveness of rt-CGM versus other methods of glucose monitoring. At a minimum, the protocols of RCTs of intensive insulin therapy options in adolescents will need to specify the type of glucose monitoring method to be used, so that the effects of differences in insulin therapy can be distinguished from differences in the glucose monitoring methods.
In our original evidence report, we highlighted the need for studies in the elderly. However, for this report on Future Research Needs, the stakeholders made it clear that the entire adult population with type 2 diabetes remains a high priority for future research. For this important population, RCTs are the strongest and most appropriate study design for determining the comparative effectiveness of the sensor augmented pump compared with other insulin delivery methods. As indicated above, such trials should be accompanied by efforts to assess the comparative effectiveness of rt-CGM versus other methods of glucose monitoring, with protocols that clearly specify the type of glucose monitoring method to be used.
Since the cost of long-term RCTs may be prohibitive for addressing all of the outcomes of interest for all of the comparisons of interest, prospective observational studies will continue to have a role. Observational studies will be particularly important in determining the comparative effectiveness of CSII versus MDI and rt-CGM versus SMBG in terms of clinically relevant long-term microvascular and macrovascular outcomes.
Identification of Ongoing Research
We searched clinical research repositories and research-related sites including ClinicalTrials.gov, NIH Reporter, the Canadian Institutes of Health Research, the World Health Organization Clinical Trials Registry, and the European Union Clinical Trials Register to identify ongoing/recently completed studies related to insulin pump therapy and blood glucose monitoring for insulin-requiring patients with diabetes. Appendix B includes a summary of findings from these searches. Thirteen potentially relevant studies were identified.
- Results - Insulin Delivery and Glucose Monitoring Methods: Future Research NeedsResults - Insulin Delivery and Glucose Monitoring Methods: Future Research Needs
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