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PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort.
Diabetes Obes Metab. 2007 May; 9(3):428-34.DO

Abstract

AIM

PREDICTIVEtrade mark (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a large, multi-national, observational study assessing the safety and efficacy of insulin detemir. We report the study design, population characteristics and baseline observations, including cross-sectional analysis, from 19 911 patients with type 1 or 2 diabetes.

METHODS

Patients with type 1 or 2 diabetes requiring basal insulin are prescribed insulin detemir and followed up for 12-52 weeks. Data on demographics, haemoglobin A(1c) (HbA(1c)), fasting glucose, within-subject fasting glucose variability and weight are collected from patient records (and/or recall for hypoglycaemia). A negative binomial distribution model is used to assess the influence of predictive/confounding variables on hypoglycaemic episodes in insulin-treated patients at baseline. Multi-factorial analysis of covariance is used to evaluate the association of the variables with current body weight and within-subject fasting glucose variability.

RESULTS

Total hypoglycaemic episodes in the 4 weeks prior to study start were 47.5 per patient-year in patients with type 1 and 9.2 per patient-year in patients with type 2 diabetes. The frequency of hypoglycaemia in insulin-treated patients showed a significant, positive association with duration of diabetes, number of insulin injections and fasting glucose variability but was inversely related to HbA(1c), fasting glucose and body mass index. Weight showed a significant positive association with gender (male > female) and insulin dosage. Weight was also positively associated with fasting glucose variability in patients with type 1 diabetes, and age and number of injections in patients with type 2 diabetes.

CONCLUSIONS

These baseline data showed that, in addition to the established relationship with intensive treatment and HbA(1c), frequency of hypoglycaemia was positively associated with fasting glucose variability. Follow-up data from PREDICTIVE will provide insights on insulin detemir in diabetes management.

Authors+Show Affiliations

Praxis Lüddeke/Trauner, Munich, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17391171

Citation

Lüddeke, H-J, et al. "PREDICTIVE- a Global, Prospective Observational Study to Evaluate Insulin Detemir Treatment in Types 1 and 2 Diabetes: Baseline Characteristics and Predictors of Hypoglycaemia From the European Cohort." Diabetes, Obesity & Metabolism, vol. 9, no. 3, 2007, pp. 428-34.
Lüddeke HJ, Sreenan S, Aczel S, et al. PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab. 2007;9(3):428-34.
Lüddeke, H. J., Sreenan, S., Aczel, S., Maxeiner, S., Yenigun, M., Kozlovski, P., Gydesen, H., & Dornhorst, A. (2007). PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes, Obesity & Metabolism, 9(3), 428-34.
Lüddeke HJ, et al. PREDICTIVE- a Global, Prospective Observational Study to Evaluate Insulin Detemir Treatment in Types 1 and 2 Diabetes: Baseline Characteristics and Predictors of Hypoglycaemia From the European Cohort. Diabetes Obes Metab. 2007;9(3):428-34. PubMed PMID: 17391171.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. AU - Lüddeke,H-J, AU - Sreenan,S, AU - Aczel,S, AU - Maxeiner,S, AU - Yenigun,M, AU - Kozlovski,P, AU - Gydesen,H, AU - Dornhorst,A, AU - ,, PY - 2007/3/30/pubmed PY - 2007/6/23/medline PY - 2007/3/30/entrez SP - 428 EP - 34 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 9 IS - 3 N2 - AIM: PREDICTIVEtrade mark (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a large, multi-national, observational study assessing the safety and efficacy of insulin detemir. We report the study design, population characteristics and baseline observations, including cross-sectional analysis, from 19 911 patients with type 1 or 2 diabetes. METHODS: Patients with type 1 or 2 diabetes requiring basal insulin are prescribed insulin detemir and followed up for 12-52 weeks. Data on demographics, haemoglobin A(1c) (HbA(1c)), fasting glucose, within-subject fasting glucose variability and weight are collected from patient records (and/or recall for hypoglycaemia). A negative binomial distribution model is used to assess the influence of predictive/confounding variables on hypoglycaemic episodes in insulin-treated patients at baseline. Multi-factorial analysis of covariance is used to evaluate the association of the variables with current body weight and within-subject fasting glucose variability. RESULTS: Total hypoglycaemic episodes in the 4 weeks prior to study start were 47.5 per patient-year in patients with type 1 and 9.2 per patient-year in patients with type 2 diabetes. The frequency of hypoglycaemia in insulin-treated patients showed a significant, positive association with duration of diabetes, number of insulin injections and fasting glucose variability but was inversely related to HbA(1c), fasting glucose and body mass index. Weight showed a significant positive association with gender (male > female) and insulin dosage. Weight was also positively associated with fasting glucose variability in patients with type 1 diabetes, and age and number of injections in patients with type 2 diabetes. CONCLUSIONS: These baseline data showed that, in addition to the established relationship with intensive treatment and HbA(1c), frequency of hypoglycaemia was positively associated with fasting glucose variability. Follow-up data from PREDICTIVE will provide insights on insulin detemir in diabetes management. SN - 1462-8902 UR - https://www.unboundmedicine.com/medline/citation/17391171/PREDICTIVE__a_global_prospective_observational_study_to_evaluate_insulin_detemir_treatment_in_types_1_and_2_diabetes:_baseline_characteristics_and_predictors_of_hypoglycaemia_from_the_European_cohort_ L2 - https://doi.org/10.1111/j.1463-1326.2006.00677.x DB - PRIME DP - Unbound Medicine ER -