Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial.
OBJECTIVE
After achieving glycaemic control, many type 2 diabetic patients relapse to clinically significant levels of hyperglycaemia. We sought to determine the optimal frequency of telephone contact by nurse practitioners that was necessary to prevent glycaemic relapse.


METHODS
This parallel, randomised controlled trial ran from June 2002 to February 2006 at an academic medical centre, studying 164 type 2 diabetic patients who had recently achieved glycaemic control. Participants were randomly assigned by sequential, concealed, computer-generated allocation to a 2 year maintenance strategy consisting of: (1) routine follow-up (n = 54); (2) routine follow-up and quarterly telephone contact (n = 55); or (3) routine follow-up and monthly telephone contact (n = 55). Blinding was not possible. The primary outcome was cumulative incidence of glycaemic relapse, defined as an increase in HbA(1c) of > or =1%; all participants were analysed. Cumulative incidence and prevalent proportions were compared. Weight change and hypoglycaemia were also assessed.


RESULTS
All participants randomised were included in the analyses. The study was completed by 90% of participants and intervention fidelity was high. At 24 months, the cumulative incidence of relapse was 41%. At 12 months, prevalent proportions of relapse were 20%, 14% and 15% for control, quarterly contact and monthly contact, respectively. At 24 months, they were 25%, 21% and 29%, respectively. There was no statistically significant difference in cumulative incidence or prevalent proportions of relapse among the study arms. Adverse events did not differ between study arms.


CONCLUSIONS
This first randomised controlled trial to test an intervention to prevent glycaemic relapse found that regularly scheduled telephone contact by a nurse practitioner was no more effective than routine follow-up care in preventing glycaemic relapse.
Huizinga
M M
MM
Johns Hopkins University School of Medicine, 2024 E Monument Street, Suite 2-500, Baltimore, MD 21205, USA. mhuizinga@jhmi.edu
Gebretsadik
T
T
Garcia Ulen
C
C
Shintani
A K
AK
Michon
S R
SR
Shackleford
L O
LO
Wolff
K L
KL
Brown
A W
AW
Rothman
R L
RL
Elasy
T A
TA
D000293:Adolescent; D000328:Adult; D000368:Aged; D003153:Community Health Services; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D018579:Patient Selection; D055502:Secondary Prevention; D016896:Treatment Outcome
D007004:Hypoglycemic Agents