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Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.

Effectiveness of early intensive therapy on β-cell preservation in type 1 diabetes.

Collaborators (276)

Slover R, Chase H, Maahs D, Banion C, Cain C, Chan CM, Chan CL, Fiallo-Scharer R, Howard D, Kassels S, Michels A, Nadeau K, Wadwa P, Hoops S, Polsky S, Schweiger BM, Gottlieb P, Mansoori L, Messer L, Sullivan S, Gage V, DiMeglio LA, Stroud L, Meier J, Hannon T, Sanchez J, Woerner S, Evans CM, Jolivette H, Cabrera S, Simms E, Pottorff T, Goldyn A, Fuqua J, Stancombe K, Behrmann M, Eugster E, Haddad N, Pescovitz M, Nebesio T, Viswanathan V, Lewis K, Ford L, Hufferd R, Buckingham BA, Wilson DM, Benassi K, Aye T, Kumar R, Patel P, Shah A, Shah S, Kunselman E, Fuld K, Forghani N, Block J, Caswell K, Bremer AA, Russell W, Brown A, Moore D, Black M, Brendle F, Weinzimer SA, Tamborlane WV, Sherr J, Cengiz E, Tichy E, Palau-Collazo M, Kim G, Sherwin R, Steffen A, Weyman K, Zgorski M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Stevens B, Buckingham BA, Beck RW, Ruedy KJ, Chase H, Wilson DM, Block J, Weinzimer SA, Tamborlane WV, Kaufman F, White NH, Greenbaum CJ, Winer K, Leschek E, Skyler JS, Buckingham BA, Beck RW, Ruedy KJ, Slover R, Weinzimer SA, DiMeglio LA, Bremer AA, Chase H, Wilson DM, Tamborlane WV, Sherr J, Russell W, Block J, Messer L, Steffen A, Woerner S, Brown A, Kollman C, Cheng P, Leschek E, Winer K, White NH, Greenbaum CJ, Skyler JS, Marcovina S, Palmer J, Chmielewski J, Gaur V, Wilson A, Winter W, Pittman D, Scott MS, Sokolowski D, Sheldon M, Higgins H, Babu S, Eisenbarth GS, Yu L, Nechtman J, McIndoe R, Liu H, Tsalikian E, Tansey MJ, Coffey J, Cabbage J, Salamati S, Mauras N, Fox LA, Englert K, Permuy J, Sikes K, Buckingham BA, Wilson DM, Clinton P, Caswell K, Weinzimer SA, Tamborlane WV, Sherr J, Steffen A, Weyman K, Zgorski M, Tichy E, White NH, Arbelaez AM, Levandoski L, Starnes A, Beck RW, Ruedy KJ, Kollman C, Xing D, Hall C, Stevens B, Grave GD, Winer KK, Leschek E, Skyler JS, Greenbaum CJ, Kenyon NS, Rafkin L, Santiago I, Sosenko JM, Fradkin J, Leschek E, Savage P, Spain L, Blumberg E, Beck G, Braun J, Brillon D, Gubitosi-Klug R, Laffel L, Veatch R, Wallace D, Lernmark A, Lo B, Mitchell H, Naji A, Nerup J, Orchard T, Steffes M, Tsiatis A, Zinman B, Skyler JS, Anderson M, Atkinson M, Bourcier K, Becker D, Bingley P, Blum J, Bosi E, Buckner J, Chase H, Clare-Salzler M, Colman P, DiMeglio L, Eisenbarth GS, Fathman C, Gitelman S, Goland R, Gottlieb P, Grave G, Greenbaum CJ, Hering B, Herold K, Insel R, Krischer JP, Marks J, Moran A, Palmer JP, Peakman M, Pugliese A, Raskin P, Roncarolo MG, Russell W, Savage P, Schatz D, Sherwin R, Siegelman M, Simell O, Thomas J, Trucco M, Wentworth J, Wherrett D, Wilson DM, Winter W, Fradkin J, Leschek E, Spain L, Benoist C, Bluestone J, Brown D, Cowie C, Harrison L, Jordan S, Kaufman FR, Lachin JM, Mahon J, Nanto-Salonen K, Nepom G, Orban T, Parkman R, Pescovitz M, Peyman J, Ridge J, Rodriguez H, Wagner J, Ziegler A, Skyler JS, Bourcier K, Greenbaum CJ, Krischer JP, Leschek E, Rafkin L, Savage P, Spain L, Cowie C, Foulkes M, Krause-Steinrauf H, Lachin JM, Malozowski S, Peyman J, Ridge J, Zafonte SJ.

Abstract

OBJECTIVE:

To assess effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at 1 year.

RESEARCH DESIGN AND METHODS:

Sixty-eight individuals (mean age 13.3 ± 5.7 years; 35% female, 92% Caucasian) were randomized to HCLC followed by SAP therapy (intensive group; N = 48) or to the usual-care group treated with multiple daily injections or insulin pump therapy (N = 20). Primary outcome was C-peptide concentrations during mixed-meal tolerance tests at 12 months.

RESULTS:

Intensive-group participants initiated HCLC a median of 6 days after diagnosis for a median duration of 71.3 h, during which median participant mean glucose concentration was 140 mg/dL (interquartile range 134-153 mg/dL). During outpatient SAP, continuous glucose monitor (CGM) use decreased over time, and at 12 months, only 33% of intensive participants averaged sensor use ≥6 days/week. In the usual-care group, insulin pump and CGM use were initiated prior to 12 months by 15 and 5 participants, respectively. Mean HbA1c levels were similar in both groups throughout the study. At 12 months, the geometric mean (95% CI) of C-peptide area under the curve was 0.43 (0.34-0.52) pmol/mL in the intensive group and 0.52 (0.32-0.75) pmol/mL in the usual-care group (P = 0.49). Thirty-seven (79%) intensive and 16 (80%) usual-care participants had a peak C-peptide concentration ≥0.2 pmol/mL (P = 0.30).

CONCLUSIONS:

In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.

PMID:
24130350
[PubMed - indexed for MEDLINE]
PMCID:
PMC3836135
Free PMC Article
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