NASHVILLE, Tenn. — For the approximately 30% of patients with type 2 diabetes who are unable to reach HbA1c targets with multiple daily injections, pump therapy (CSII) may offer significant benefits for glycemic control and treatment satisfaction, according to a new data presented at the American Association of Clinical Endocrinologists (AACE) 24th Annual Scientific & Clinical Congress.
OpT2mise was a randomized controlled trial that compared CSII with multiple daily injections and the latest findings from it suggest that switching to CSII from optimized multiple daily injection therapy may allow many patients with poorly controlled type 2 diabetes to decrease their HbA1c values and reach HbA1c goals.
In addition, the findings suggest that these benefits may be achievable with no increased exposure to hypoglycemia. The researchers found that those who switched to CSII required 20% less insulin and experienced improved treatment satisfaction.
The benefits seen with the switch to CSII appeared to be independent of baseline C-peptide and anti-GAD antibody concentrations.
“The pump is not for everyone. It just needs to be an option because there are some patients who can benefit from it,” said study investigator Ruth Weinstock, MD, who is the division chief of Endocrinology, Diabetes and Metabolism at State University of New York (SUNY) Upstate Medical University in Syracuse.
“I have used pumps for many years in type 1 diabetes, and I was impressed with how well the patients do on it. So, we needed to see how well they worked in type 2 diabetes.”
Weinstock said therapy intensification in poorly controlled type 2 diabetes, in many cases, may require insulin, and it is important that patients have treatment options.
The researchers conducted a study with 495 patients with poor glycemic control on multiple daily injections. After a run-in period, 331 patients were found to have HbA1c levels between 8% and 12%.
Of these patients, 163 patients continued of multiple daily injections, and 168 were switched to CSII for 6 months. The investigators evaluated glycemia with two blinded continuous glucose monitoring (CGM) studies and with periodic HbA1c assessments. They measured treatment satisfaction through questionnaires.
The researchers evaluated response dependence on autoimmune status and endogenous insulin by stratifying patients according to pre-randomization anti-GAD Ab concentrations (<1 or ≥1 U/mL) and C-peptide concentration quartiles (using cutoff values of 156 pmol/L, 310 pmol/L and 569 pmol/L).
The mean HbA1c level was 9% in both groups at baseline. By 6 months, the change in HbA1c was –1.1% for the pump therapy arm compared with –0.4% for multiple daily injections arm. This resulted in a between-group difference of –0.7% in favor of CSII (95% CI, –0.9 to –0.4), according to the researchers.
Further, patients in the CSII arm were found to be 1.9-fold more likely to achieve a 6-month HbA1c level of less than 8% compared with those in the multiple daily injections group (P<.001).
The study also demonstrated that total daily insulin doses were 97 U for the CSII group compared with 122 U for the multiple daily injections arm at 6 months (P<.0001). The greater decreases in HbA1c levels at 6 months were significantly associated with improved treatment satisfaction in the CSII arm. However, that was not the case in the multiple daily injections arm.
The researchers found there were no significant differences in HbA1c levels between patients with or without anti-GAD antibodies in either group. The same was true for C-peptide concentration quartile in either arm.
“This is the first study of its kind in terms of randomized controlled trial,” Weinstock said in an interview with Endocrinology Advisor. “I think the take-home message is that pump therapy should be an option. It did not increase the risk of hypoglycemia.”
- Lee S et al. Abstract #231. Presented at: American Association of Clinical Endocrinologists (AACE) 24th Annual Scientific & Clinical Congress; May 13-17, 2015; Nashville, Tenn.